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Journal of

Personalized
Medicine

Systematic Review
Quality of Life and Audiological Benefits in Pediatric Cochlear
Implant Users in Romania: Systematic Review and Cohort Study
Gina Gundacker 1, *, Delia Emilia Trales 2 and Horatiu Eugen Stefanescu 2

1 Life Science Department, University of Applied Sciences Technikum Vienna, 1200 Vienna, Austria
2 Department of Otolaryngology, Victor Babes, Medical and Pharmaceutical University,
300041 Timis, oara, Romania; [email protected] (D.E.T.); [email protected] (H.E.S.)
* Correspondence: [email protected]

Abstract: Profound sensorineural hearing loss (SNHL) can be successfully treated with a cochlear
implant (CI), and treatment is usually accompanied by increased quality of life (QoL). Therefore, the
aim of this study was to investigate generic and health-related QoL, as well as the level of audiological
outcomes, of CI users, in addition to whether Qol can be restored to the extent of those with normal
hearing. Furthermore, different implantation timepoints were compared (early vs. late), and a
possible correlation between health and generic QoL questionnaires was investigated. The outcomes
from 93 pediatric CI users from Romania were analyzed in the study. Two QoL questionnaires (SSQ12,
AQoL-6D), as well as the HSM sentence test and Soundfield measurements, were assessed. The
outcomes revealed that the CI users were able to achieve the same QoL as their age- and-gender
matched peers with normal hearing, and hearing was restored with good speech comprehension. No
significant difference between early- and late-implanted children was detected, although a tendency
of a better Word Recognition Score (+10%) in the early-implanted group was discovered. A moderate
and significant correlation between the generic and health-related Qol questionnaire was observed.
Audiological examinations are still the standard practice by which to measure the benefit of any
hearing intervention; nonetheless, generic and health-related QoL should be assessed in order to
provide a full picture of a successful and patient-satisfactory cochlear implant procedure.

Keywords: quality of life; sensorineural hearing loss; cochlear implant; audiometry; rehabilitation
Citation: Gundacker, G.; Trales, D.E.;
Stefanescu, H.E. Quality of Life and
Audiological Benefits in Pediatric
Cochlear Implant Users in Romania:
Systematic Review and Cohort Study.
1. Introduction
J. Pers. Med. 2023, 13, 1610. https:// Hearing loss (HL) is the most common sensory impairment, and, as of today, the
doi.org/10.3390/jpm13111610 only one which can be replaced with an implant [1]. According to the world report on
hearing from 2021, conducted by the World Health Organization (WHO), more than 5%
Academic Editors: Georg Mathias
Sprinzl and Astrid Magele
of the world’s population, i.e., roughly 460 million individuals, have moderate to severe
hearing loss which would influence their everyday lives if left untreated [2]. Of these
Received: 13 October 2023 people, about 34 million children are affected with disabling hearing loss [3]. Hearing-
Revised: 7 November 2023 impaired people suffer from restrictions regarding their participation in daily life [3].
Accepted: 9 November 2023 Furthermore, individuals with communication difficulties have a risk of restricted cognitive
Published: 15 November 2023
skills, including reduced attention and concentration spans as well as lower than average
memory recall [2]. This can be avoided if they receive the right support and treatment as
soon as possible. Disabling hearing loss often also leads to low self-esteem, feelings of
Copyright: © 2023 by the authors.
seclusion, and social isolation, causing depression and anxiety [2,3]. Hence, people who
Licensee MDPI, Basel, Switzerland. are hearing-impaired often report a lower overall quality of life (QoL) [2].
This article is an open access article Depending on the type and severity of hearing impairment, several treatment options
distributed under the terms and are possible, from conventional hearing aids to medical interventions utilizing passive
conditions of the Creative Commons middle ear prostheses, active middle ear or bone conduction implants, and cochlear im-
Attribution (CC BY) license (https:// plants (CI). Cochlear implantation often requires personalized rehabilitation to not only
creativecommons.org/licenses/by/ hear sounds, but to enhance speech perception, speech production, and language devel-
4.0/). opment [3,4]. With the use of a CI, approximately one million partly or completely deaf

J. Pers. Med. 2023, 13, 1610. https://doi.org/10.3390/jpm13111610 https://www.mdpi.com/journal/jpm


J. Pers. Med. 2023, 13, 1610 2 of 21

individuals worldwide have been able to regain functional hearing [5]. The literature on
children with CIs has demonstrated significant outcomes, especially in the development
and perception of speech [6]. Children who have received cochlear implants at a young
age have developed speech perception skills that allow them to develop fluent spoken
language at a rate resembling that of children with normal hearing [6,7].
The progress and benefit of a cochlear implant can be measured via objective measures
such as pure tone audiometry, which is measured at certain frequencies and sound levels [8].
Also, sentence tests are regularly applied in order to check whether speech comprehension
is developing. The Hochmair–Schulz–Moser (HSM) sentence test is one example of such
an assessment, and was developed especially for CI users, applying everyday words to test
their speech perception [9]. In general, beneficial audiometric measurements do not always
indicate a better QoL [10]. However, since the aim of such interventions is to improve
quality of life, attention should also be focused on how the person subjectively perceives
their new hearing. A vast amount of different QoL questionnaires, validated and translated
into numerous languages, are available and are used to validate the benefit to the patient.
These tests can be taken into account for future treatments and can be compared to other,
similar interventions [11].
Quality of life questionnaires validate individuals’ subjective perception of different
dimensions of life, such as mobility, mental health, sight, hearing, etc. One can distinguish
between generic and disease-specific QoL questionnaires and their respective impacts on
quality of life [10]. The evaluation of quality of life is still not a standard clinical routine
measure to evaluate the benefit of an intervention; thus, the available literature on the
quality of life of CI patients is very heterogenous.
Therefore, the aim of this study was to conduct a systematic literature review on the
generic QoL of CI users, as well as to provide additional audiological data and QoL scores
from a pediatric study cohort of CI users from Romania. Therefore, the following points
were the focus of this paper:
• A systematic review of the current literature regarding the QoL of CI users was
conducted to obtain an overview of the generic QoL questionnaires utilized in the
literature, and to see which questionnaires were employed for pediatric CI users.
• The generic QoL of the Romanian CI user study cohort was assessed, and they were
compared with age- and gender-matched peers with normal hearing.
• Data from the study cohort were collected to assess the level of speech comprehension
and hearing ability of pediatric CI users in Romania using the translated and recorded
HSM sentence test and pure tone audiometry.
• Possible influencing factors, such as early-implanted (≤3 years) CI users versus late-
implanted (>3 years) children, were investigated.
• Finally, possible correlations between the generic and health-related quality of life
questionnaires were assessed.

2. Materials and Methods


The methods can be divided into two main areas, with one area describing the methods
section for the systematic review. The second main item contains the data collection
methods for the Romanian study group of pediatric CI users.

2.1. Systematic Review


The systematic review was conducted according to the PRISMA guidelines [12]. The
studies were searched in the PubMed database according to the search terms defined in
Table 1. Inclusion and exclusion criteria were defined based on PRISMA guidelines [12]
using the so-called PICOS classification (Population, Intervention, Comparators, Outcomes,
and Study Design), and are listed in Table 2. The systematic review was not registered.
J. Pers. Med. 2023, 13, 1610 3 of 21

Table 1. Search terms and hits for the literature search in the PubMed database.

Search Steps Search Terms Hits


1 ((Quality of Life) AND (cochlea * implant *)) 903
2 Limit NOT (Health Related Quality of Life) 903
3 Filter: last five years for recent data (from 05/07/2017 to 05/07/2022) 386

Table 2. Inclusion and exclusion criteria for literature screening.

Inclusion Criteria
Subjects of any age, gender, or ethnicity with any hearing loss or single-sided deafness (SSD),
Population
as well as and their legal representatives
Intervention/treatment Cochlear implantation
Comparator Not applicable
Outcomes Generic quality of life scores
All studies with original data, including case series, case–control, and longitudinal studies.
Study design Systematic reviews without original data, as well as acknowledgements, recommendations, or general
topic descriptions were excluded.
Exclusion Criteria
Different device or treatment
Not a clinical study in humans
Other type of hearing loss (not SNHL, MHL, or SSD)
Topic not related to hearing loss or its treatment
Publication lacking sufficient information for evaluation
Overlap of data

The Oxford level of evidence guidelines were considered in order to evaluate the
quality of the included papers [13]. The five levels were defined based on the possible
outcomes/research standards, with level I representing the best and level V representing
the worst reporting standard. In our analysis, for example, we considered the study design,
the number of study participants, the follow-up examinations, etc.

2.2. Data Collection from the Study Cohort in Romania


2.2.1. Participants
For this study, 93 participants, with a mean age of 10.9 ± 5.0 years, were included. The
study cohort consisted of 35 female and 58 male children and adolescents from Romania
who were suffering from sensorineural hearing loss accompanied with a hearing threshold
higher than 70 dB. Every participant was fitted unilaterally with a cochlear implant (Combi
40+, Pulsar, Sonata, Mi1000 Concerto, Mi1200 Synchrony) and an audio processor (behind
the ear: Opus, Opus 2, Sonnet, Sonnet 2, Tempo+; single unit: Rondo, Rondo 2, Rondo 3)
from MED-EL (MED-EL GesmbH, Innsbruck, Austria). Adolescents and adults up to
20 years of age were included if the implantation had been carried out in childhood. For
this reason, the age range extended from 2 to 20 years.

2.2.2. Data Collection


Data were collected during clinical routine measurements at the clinic of Timisoara
(Municipal Hospital, Strada Gheorghe Dima nr. 5, Timisoara, Romania), as well as from
a CI self-help group camp in Eforie. The relevant patient outcomes gathered by respon-
sive clinical personnel were provided in a pseudonymized form. The parents or legal
representatives provided their consent for the collection of their children’s data.
J. Pers. Med. 2023, 13, 1610 4 of 21

2.2.3. Quality of Life Assessments


The QoL questionnaires were completed by the participants themselves, using either
the online form or the printed version. If the study participants were too young, the
questionnaires were completed with the help of their parents or legal representatives.

Assessment of Quality of Life (AQoL-6D)


To measure the generic QoL, the AQoL-6D total utility score, along with the individual
utility scores of the six dimensions, were assessed. These dimensions were as follows:
Independent Living, Mental Health, Coping, Relationships, Pain, and Senses [14]. The
AQoL with six dimensions was considered because the participants were children and
adolescents, and the questionnaire with eight dimensions is designed for adults only [15].
The AQoL-6D consists of 20 items, each with four to six possible answers to describe
the subject’s situation [14]. Each answer option is assigned a numerical value from 1–6,
depending on how many answers are available, and the evaluation tools provided by
the AQoL-Homepage convert the absolute outcomes into weighted utility scores [14,16].
In general, the total utility score and the utility sub-scores of the six dimensions for the
AQoL-6D range from 0 to 1, with 0 being the worst and 1 being the best possible result,
indicating a perfect QoL [14].

Speech, Spatial and Qualities of Hearing Scale (SSQ12)


The SSQ12 consists of twelve questions separated into three main dimensions and
an overall outcome [6]. Each question is answered using a Likert scale from 0 to 10. The
average of each category (speech, spatial, quality of hearing, and the overall average) is
used for the outcome calculations. The resulting outcomes range from 0 to 10, with 10 being
the best possible result and 0 the worst. Thus, a score of 10 represents no limitations on
QoL due to hearing impairment [17].

2.2.4. Audiological Measurements


Sound Field Audiometry (Clinical Set-Up)
Sound field measurements are frequently performed in routine audiological exam-
inations to determine the hearing thresholds over several frequencies [18]. Calibrated
loudspeakers (Pioneer Corp., S-SP 50, Tokyo, Japan) are placed in front of the participant,
and sounds of different volumes and frequencies are presented via an audiometer (Intera-
coustics A/S, AA222, Middelfart, Denmark) in a soundproof room. The non-implanted
side is plugged and covered to determine the hearing level of the implanted ear [19].

Speech Audiometry (Camp Set-Up)


The Hochmaier–Schulz–Moser (HSM) sentence test was the assessment of choice for
this study where recited sentences must be repeated by the attendant [20]. It was specifically
developed to assess the speech comprehension of CI users, and consists of 30 lists with
20 daily sense sentences for each test set. Each list has a word count of 106 words [9]. The
HSM sentence test was translated into Romanian and recorded by a professional native
male speaker. The results ranged from 0% to 100%, with 100% representing a perfect
intelligibility of speech.

2.2.5. Data Analysis


The primary AQoL-6D analysis was conducted with the evaluation tool provided by
the AQoL Homepage [14] for the statistical software SPSS (IBM Corp.; IBM SPSS Statistics
29; Armonk, NY, USA). Statistical analysis was carried out using the GraphPad PRISM
statistical software (GraphPad Software Inc.; demo version or latest version 9.0.0; San Diego,
CA, USA).
The pure tone averages (PTAs) for hearing thresholds with frequencies of 0.5, 1, 2, and
4 kHz were calculated [19,21] for further comparative statistical analyses.
The pure tone averages (PTAs) for hearing thresholds with frequencies of 0.5, 1, 2
and 4 kHz were calculated [19,21] for further comparative statistical analyses.
All data sets were tested for normal distribution by applying the Shapiro–Wilk tes
J. Pers. Med. 2023, 13, 1610 with a confidence level of 95%, resulting in no normal distribution. Nonparametric 5 of 21 statis
tical tests like the Mann–Whitney U-test, the Spearman rank correlation test, and the
Dunn’s multiple comparison were also used. A significance level with an alpha value o
0.05 All
was data
setsets
forwere tested for normal distribution by applying the Shapiro–Wilk test with
all tests.
a confidence level of 95%, resulting in no normal distribution. Nonparametric statistical
tests like the Mann–Whitney U-test, the Spearman rank correlation test, and the Dunn’s
3. Results
multiple comparison were also used. A significance level with an alpha value of 0.05 was
set forThere are two primary sections in the results section. The first describes the system
all tests.
atic review’s outcomes. The results of the Romanian study group of pediatric CI users are
3. Results in the second main part. Furthermore, unless otherwise specified, all results and
included
numerical values
There are are presented
two primary sections as theresults
in the mean section.
and standard
The firstdeviation (SD).
describes the systematic
review’s outcomes. The results of the Romanian study group of pediatric CI users are
included in the second
3.1. Systematic Reviewmain part. Furthermore, unless otherwise specified, all results and
numerical values are presented as the mean and standard deviation (SD).
The presented outcomes of this systematic review include the results of the screening
process; the investigation
3.1. Systematic Review of the quality of life questionnaires for adults and children tha
are represented
The presentedinoutcomes
the current literature;
of this and,
systematic finally,
review the the
include evaluation
results ofof the
the extracted stud
screening
ies.
process; the investigation of the quality of life questionnaires for adults and children that
are represented in the current literature; and, finally, the evaluation of the extracted studies.
3.1.1. Screening Process
3.1.1. Screening Process
The process and outcomes of the systematic literature search can be seen in the flow
The process and outcomes of the systematic literature search can be seen in the flow
chart in Figure 1. First, the articles were selected according to the title and abstract, leaving
chart in Figure 1. First, the articles were selected according to the title and abstract, leaving
77 papers
77 papersforforthe
the second
second screening,
screening, whichwhich involved
involved the
the full fullFollowing
text. text. Following the second
the second
screening, data extraction was performed for 25 publications. The screening
screening, data extraction was performed for 25 publications. The screening outcomes and outcomes and
reasonsfor
reasons forexclusion
exclusion (n157)
(n = = 157)
are are outlined
outlined in Figure
in Figure 1. 1.

Figure1.1.Flow
Figure Flowdiagram
diagramof of
thethe
study selection
study process
selection according
process to the PRISMA
according guidelines
to the PRISMA [12]
guidelines [12
(search conducted on 05.07.2022). QoL = quality of life.
(search conducted on 05.07.2022). QoL = quality of life.
J. Pers. Med. 2023, 13, 1610 6 of 21

An additional search, specifically for the AQoL with the search terms (cochlear im-
plant *) AND (aqol), was conducted on 28.7.2022/9:00. Two publications were identified,
but only one [15] met the inclusion criteria described in Table 2. Finally, 26 publications
were included for further data extraction.

3.1.2. Adult CI Users and Their Generic QoL


The extracted data of the generic QoL scores for adult CI users are presented in Table 3.
The darker blue fields emphasize the total scores, while the lighter green and blue fields
highlight the subcategories that can also be merged. An example of this can be seen for the
AQoL at the bottom of Table 3, where the light blue subcategories of independent living,
pain, and senses are combined to form the category of physical super dimension. The
given standard deviation was calculated for the summarized mean values of the included
publications. If only one publication is provided for a number of papers, it indicates that the
values were extracted directly from the published article. As shown in Table 3, the quantity
of the study cohort mostly varied according to the number of subjects from whom data
were collected. The reason for this was that several questionnaires were administered, but
did not always include the entire group. In the follow-up investigations, it also happened
that patients were lost to follow-up for unknown reasons.
In general, it can be seen in Table 3 that the QoL was nearly always higher for all
scores after a cochlear implant intervention. However, the dimensions and numerical ranks
differed so much that the questionnaires could not be compared with each other.

3.1.3. Pediatric CI Users and Their Generic QoL


Table 4 shows the generic QoL outcomes for children and adolescents. The systematic
review included three QoL questionnaires for children. For the children and adolescents,
only postoperative outcomes were recorded. As with the adult population, a higher
outcome of the questionnaire generally indicates a better quality of life. It was visible that
there is no uniform way to measure quality of life in children. In general fewer data were
available for children.
J. Pers. Med. 2023, 13, 1610 7 of 21

Table 3. Extracted data regarding the systematic review for adults. All questionnaires refer to the generic quality of life of cochlear implant users before and after
the intervention. If more than one publication is indicated, the values correspond to the mean value of these studies and their standard deviation (SD), unless
otherwise stated. If medians and ranges are specified, they are listed separately. Darker blue fields represent total scores and lighter green or blue fields highlight the
subcategories of the SF-36.

n Specific Test for n Whole n


Evaluation Mean Age Mean Age SD
Range Category SD Median Range Mean Median Study Publications Publications
Time Score [years] [years]
Values Values Cohort Included

1. GBI (=Glasgow Benefit Inventory)


Anzivino et al., 2019 [22]
Calvino et al., 2022 [23]
Hey et al., 2019 [24]
Total 39.6 9.99 - - 240 - 56.4 11.6 280 6
Sivonen et al., 2021 [25]
Sorrentino et al., 2020 [26]
Tang et al., 2017 [27]
General Postoperative 51.19 14.40 25 10.8–33.33 Calvino et al., 2022 [23]
Forli et al., 2019 [28]
Social 28.65 11.86 0 0–8.33 Hey et al., 2019 [24]
322 27 57.0 11.2 391 7 Peters et al., 2021 [29]
Sivonen et al., 2021 [25]
Physical 13.70 17.79 0 0–0 Sorrentino et al., 2020 [26]
Tang et al., 2017 [27]
Anzivino et al., 2019 [22]
−100 to +100 Total 38.00 9.80 - - 67 63.6 2.9 70 2
Hey et al., 2019 [24]
postoperative
General short term 38.80 27.70 25 10.8–33.33
Social (<12 months) 10.50 29.70 0 0–8.33 Hey et al., 2019 [24]
42 27 57.0 3.8 74 2
Peters et al., 2021 [29]
Physical 3.20 15.70 0 0–0
Calvino et al., 2022 [23]
Sivonen et al., 2021 [25]
Total 40.06 10.00 173 54.0 12.4 210 4
Sorrentino et al., 2020 [26]
postoperative - - - Tang et al., 2017 [27]
General long term 52.43 14.54 Calvino et al., 2022 [23]
(≥12 months) Forli et al., 2019 [28]
Social 30.46 10.88 Sivonen et al., 2021 [25]
280 57.0 12.3 317 5
Sorrentino et al., 2020 [26]
Physical 14.75 18.33 Tang et al., 2017 [27]
J. Pers. Med. 2023, 13, 1610 8 of 21

Table 3. Cont.

n Specific Test for n Whole n


Evaluation Mean Age Mean Age SD
Range Category SD Median Range Mean Median Study Publications Publications
Time Score [years] [years]
Values Values Cohort Included

2. WHOQOL (=World Health Organisation, Quality of Life)


WHOQOL-BREF (short form)
Total 66.00 11.75
Environment 59.70 4.60
- - - Chen et al., 2022 [30]
Social
0–100 59.17 7.93 97 44.4 3.6 97 4 Peter et al., 2019 [31]
realitionships Postoperative
Saraç et al., 2019 [32]
Physical health 63.50 6.82 Sousa et al., 2018 [33]
Psychosocial
61.40 10.09
health
WHOQOL-OLD (for old age)
Total 60.00 15.70
Sensory Abilities 38.10 22.60
Autonomy 63.20 17.60
Past, Present,
66.20 18.00
Future Activities Preoperative - - 34 - 73.5 4.9 34 1 Issing et al., 2020 [34]
Social
61.40 21.00
Participation
Death and Dying 61.90 30.00
Intimacy 69.30 20.20
0–100 Issing et al., 2020 [34]
Total 69.04 3.41 - - 151 - 71.5 4.1 178 3 Issing et al., 2022 [35]
Völter et al., 2018 [36]
Sensory Abilities 55.18 1.65
Autonomy 69.80 3.36
Past, Present, Postoperative 71.63 3.00
Future Activities
- - - Issing et al., 2020 [34]
118 74.4 0.9 118 2
Social Issing et al., 2022 [35]
68.90 2.49
Participation
Death and Dying 65.53 5.69
Intimacy 73.73 1.39
J. Pers. Med. 2023, 13, 1610 9 of 21

Table 3. Cont.

n Specific Test for n Whole n


Evaluation Mean Age Mean Age SD
Range Category SD Median Range Mean Median Study Publications Publications
Time Score [years] [years]
Values Values Cohort Included

3. SF-36 (=Short Form Health Survey with 36 items)


Physical health 61.51 13.21 Anzivino et al., 2019 [22]
- - 55 - 56.2 10.2 55 2
Mental health 55.05 2.06 Chen et al., 2022 [30]
Physical
57.20 55.1–57.2
Functioning
Role-Physical 56.20 49.2–56.2
Body Pain 62.80 47.3–62.8
General Health Preoperative 57.90 50.9–61.7
- - - median: range:
Vitality 53.80 46.7–60.9 30 30 1 Forli et al., 2017 [37]
35 16–54
Social
46.30 35.4–57.2
Functioning
Role-
55.30 44.8–55.3
Emotional
Mental Health 45.90 39.1–55.0
0–100
Physical health 69.20 9.30 Anzivino et al., 2019 [22]
- - 55 - 56.2 10.2 55 2
Mental health 66.43 5.37 Chen et al., 2022 [30]
Physical
57.20 55.1–57.2
Functioning
Role-Physical 56.20 49.2–56.2
Body Pain 62.80 51.6–62.8
General Health Postoperative 60.30 54.6–61.7
median: range:
Vitality 56.20 51.1–63.3 - 30 30 1 Forli et al., 2017 [37]
- - 35 16–54
Social
49.00 40.9–57.1
Functioning
Role-
55.30 55.3–55.3
Emotional
Mental Health 52.70 45.9–55.0
J. Pers. Med. 2023, 13, 1610 10 of 21

Table 3. Cont.

n Specific Test for n Whole n


Evaluation Mean Age Mean Age SD
Range Category SD Median Range Mean Median Study Publications Publications
Time Score [years] [years]
Values Values Cohort Included

4. GHSI (=Glasgow Health Status Inventory)


range:
−100 to +100 Total postoperative 66.00 2.00 23 44.2 27 1 Sivonen et al., 2021 [25]
19.5–64.8
5. EQ-5D-5L (=European Quality of Life in 5 Dimensions, 5 Level Version)
Mobility 1.65 0.95
Self-care 1.15 0.67
postoperative
Usual activities 1.45 0.83
shortterm - - 20
Pain/discomfort (<12 months) 1.55 0.60
Anxiety/
1.65 0.99
0–5 depression
- 3.0 5.8 458 1 Piromchai et al., 2021 [38]
Mobility 1.29 0.59
Self-care 1.12 0.33
Usual activities postoperative 1.47 0.72
longterm - - 17
Pain/discomfort (≥12 months) 1.47 0.51
Anxiety/
1.18 0.39
depression
6. HUI 3 (=Health Utilities Index)
preoperative 0.56 - 59
0–1 Total - - - 72.3 6.8 59 1 Sarant et al., 2019 [16]
postoperative 0.67 - 20
7. AQoL-8D (=Assessment of Quality of Life in 8 Dimensions)
Total 0.50 0.23 0.17–0.99
Physical su-
0.50 0.20 0.15–0.91
perdimension
Psycho-social
superdimen- 0.27 0.19 0.05–0.92
sion
0–1 Independent 104 - 34.8 16.6 104 1 Rostkowska et al., 2021 [15]
Preoperative 0.78 0.15 - 0.39–1
living
Pain 0.76 0.24 0.15–1
Senses 0.53 0.18 0.25–0.97
Mental health 0.53 0.16 0.25–1
Happiness 0.64 0.18 0.24–1
J. Pers. Med. 2023, 13, 1610 11 of 21

Table 3. Cont.

n Specific Test for n Whole n


Evaluation Mean Age Mean Age SD
Range Category SD Median Range Mean Median Study Publications Publications
Time Score [years] [years]
Values Values Cohort Included
Coping 0.72 0.17 0.38–1
Relationships 0.60 0.14 0.47–1
Self-worth 0.64 0.21 0.28–1
Total 0.66 0.19 0.21–0.99
Physical su-
0.62 0.20 0.18–0.96
perdimension
Psycho-social
superdimen- 0.37 0.18 0.09–1
sion
Independent
0.86 0.14 0.35–1
living Postoperative -
Pain 0.78 0.22 0.21–1
Senses 0.71 0.16 0.35–0.97
Mental health 0.60 0.13 0.29–1
Happiness 0.73 0.13 0.36–1
Coping 0.80 0.12 0.52–1
Relationships 0.70 0.14 0.47–1
Self-worth 0.81 0.14 0.39–1

Table 4. Extracted data regarding the systematic review for children. All questionnaires refer to the generic quality of life of cochlear implant users after the
intervention. If more than one publication is indicated, the values correspond to the mean value of these studies and their standard deviation (SD). If medians and
ranges are specified, they are listed separately. Darker blue fields represent total scores.

n Specific Test for n Whole n


Evaluation Mean Age Mean Age SD
Range Category SD Median Range Mean Median Study Publications Publications
Time Score [years] [years]
Values Values Cohort Included

8. PedsQL (=Pediatric Quality of Life Inventory)


Physical 74.59 23.67
Emotional postoperative 56.96 18.63
0–100 shortterm 23 2.96 5.83 458 1 Piromchai et al., 2021 [38]
Social (<12 months) 50.22 22.94
School 50.94 32.08
J. Pers. Med. 2023, 13, 1610 12 of 21

Table 4. Cont.

n Specific Test for n Whole n


Evaluation Mean Age Mean Age SD
Range Category SD Median Range Mean Median Study Publications Publications
Time Score [years] [years]
Values Values Cohort Included

Alnuhayer et al., 2020 [1]


Total 87.08 11.10 79.31 34.78–100 73 34 4.79 1.22 107 2
Hendriksma et al., 2020 [39]
Physical postoperative 90.04 2.93 89.36 40.63–100
longterm Alnuhayer et al., 2020 [1]
Emotional 72.07 15.19 73.33 25–100
(≥12 months) 81 34 3.88 0.92 566 3 Hendriksma et al., 2020 [39]
Social 75.23 12.10 78.24 10–100 Piromchai et al., 2021 [38]
School 66.20 14.53 76.50 37.5–100
9. GCBI (=Glasgow Children’s Benefit Inventory)
Aldriweesh et al., 2021 [40]
Total 58.12 5.89 127 3.54 0.24 127 2
Dev et al., 2022 [41]
Physical health 44.30 14.10
−100 to +100 postoperative
Emotion 68.10 13.20
57 3.30 1.9 57 1 Dev et al., 2022 [41]
Learning 78.90 10.70
Vitality 64.70 12.10
10. KINDL
Total 46.90 12.00
Physical
67.70 16.20
well-being
Self-esteem 42.70 22.70
School/
41.20 22.10
Kindergarten Vermi Sli Peker et al.,
0–100 postoperative 34 5.33 0.98 34 1
Social 2020 [42]
Relations 45.40 17.90
(Friends)
Emotional
41.00 17.10
Well-Being
Family 44.90 19.10
J. Pers. Med. 2023, 13, x FOR PEER REVIEW 11 of 19

J. Pers. Med. 2023, 13, 1610 13 of 21

3.1.4.
3.1.4.Quality
QualityEvaluation
Evaluationof
ofExtracted
ExtractedPublications
Publications
To
Toevaluate
evaluatethethequality
qualityof ofthe
theincluded
includedpapers,
papers,thetheOxford
Oxfordlevel
levelofofevidence
evidencewas wasused,
used,
which
whichranges
rangesfrom
fromlevel
levelIItotoV,V, with
with the
thebest
bestrating
ratingcorresponding
correspondingto tolevel
levelI.I.Most
Mostpapers
papers
indicated only level
indicated level IV
IVororIV–V,
IV–V, because
becausethey were
they casecase
were series or case–control
series studies,
or case–control which
studies,
can becan
which seenbeinseen
Figure 2. The prospective
in Figure cross-sectional
2. The prospective study bystudy
cross-sectional IssingbyetIssing
al. [35]etachieved
al. [35]
level III because
achieved long-term
level III because follow up
long-term evaluations
follow with more
up evaluations withthan
more30than
participants, as well
30 participants,
as comparison group data, were provided, and the outcomes were
as well as comparison group data, were provided, and the outcomes were presented presented clearly and
understandably to the reader. In addition, we investigated whether the
clearly and understandably to the reader. In addition, we investigated whether the studies studies had been
financially
had supported,
been financially which waswhich
supported, the case
wasforthe
13case
publications out of 26. Itout
for 13 publications canof also
26.beIt seen
can
in the
also bebar
seenchart in Figure
in the bar chart2 that 18 papers
in Figure did18not
2 that report
papers conflicts
did of interest,
not report only
conflicts four did,
of interest,
and four
only four did,
did not
andprovide
four didthis
notinformation.
provide this information.

Figure
Figure2.2.Quality
Qualityevaluation
evaluationofofthe
theincluded
includedpublications
publicationsofofthe
thesystematic
systematicreview
reviewaccording
accordingto
tothe
the
Oxford
Oxfordlevel
levelof
ofevidence
evidence[13].
[13].Additional
Additionalrepresentation
representationof
offinancial
financialsupport
supportand
andpossible
possibleconflicts
conflicts
of
ofinterest.
interest.

3.2.Data
3.2. DataCollection
Collectionfrom
fromStudy
StudyCohort
CohortininRomania
Romania
3.2.1.Assessment
3.2.1. Assessmentof ofQuality
Qualityof
ofLife
Life(AQoL-6D)
(AQoL-6D)
Figure33represents
Figure representsthe theresults
resultsof
ofthe
thetotal
totalutility
utilityscore
scoreand
and utility
utilitysub-scores
sub-scoresof ofthe
the
AQol-6D questionnaire from the pediatric CI users of this study in
AQol-6D questionnaire from the pediatric CI users of this study in blue. It is important to blue. It is important
to note
note thatthat
thethe
blueblue total
total utility
utility score
score in in
thethe left
left chart
chart ofofFigure
Figure3a3aisiscomposed
composedofofthe thesix
six
dimensions of the right bar chart (b), which provides the utility sub-scores. In general, aa
dimensions of the right bar chart (b), which provides the utility sub-scores. In general,
utilityscore
utility scoreofof00indicates
indicatesno noQoL,
QoL,while
whileaamaximum
maximumscore scoreofof11represents
representsaaperfect
perfectQoL.
QoL.
The results of the individual dimensions of the 74 participants in this
The results of the individual dimensions of the 74 participants in this study ranged in study ranged in utility
score from
utility score 0.71
fromto0.71
0.87.
to In Figure
0.87. 3, the3,highest
In Figure scores
the highest werewere
scores achieved
achievedin the
in relationships
the relation-
(0.87 (0.17)) and pain (0.87 (0.15)) dimensions. However, the participants had the lowest
ships (0.87 (0.17)) and pain (0.87 (0.15)) dimensions. However, the participants had the
results for the sub-scores of mental health (0.71 (0.20)) and coping (0.74 (0.26)).
lowest results for the sub-scores of mental health (0.71 (0.20)) and coping (0.74 (0.26)).
The total utility score of the AQoL-6D of this study was 0.79 (0.17) for the children
The total utility score of the AQoL-6D of this study was 0.79 (0.17) for the children
and adolescents who had been treated with a cochlear implant, which can be seen in the
and adolescents who had been treated with a cochlear implant, which can be seen in the
blue bar in the left bar chart of Figure 3a. Furthermore, in the left bar chart in Figure 3a,
blue bar in the left bar chart of Figure 3a. Furthermore, in the left bar chart in Figure 3a,
norm values for the total utility scores of age- and gender-matched peers with normal
norm values for the total utility scores of age- and gender-matched peers with normal
hearing are presented in green. These norm values were extracted from the publication
hearing are presented in green. These norm values were extracted from the publication by
by Maxwell et al. [43] (represented as a dark green bar), as well as from the study by
Maxwell et al. [43] (represented as a dark green bar), as well as from the study by Haw-
Hawthorne et al. [44] (represented as a light green bar). Both values from the indicated
thorne et al. [44] (represented as a light green bar). Both values from the indicated publi-
publications [43,44] were compared to the total utility score of the AQoL-6D of this study.
cations [43,44] were compared to the total utility score of the AQoL-6D of this study. Nei-
Neither the norm values of Hawthorne et al. [44] (p = > 0.999) nor those from Maxwell
ther
et al.the norm
[43] (p = values of Hawthorne
0.559) were et al. [44] (pa =significant
able to demonstrate > 0.999) nor those from
difference (p <Maxwell et al.
0.05) between
[43] (p = 0.559) were able to demonstrate a significant difference
the total utility score of CI users and children with normal hearing. (p < 0.05) between the total
utility score of CI users and children with normal hearing.
J.J.Pers.
Pers.Med.
Med.2023,
2023,13,
13,xxFOR
FORPEER
PEERREVIEW
REVIEW 12 of
12 of 19
19
J. Pers. Med. 2023, 13, 1610 14 of 21

p = 0.559
p = 0.559
p > 0.999
p > 0.999

1.0 1.0
1.0 1.0

Subscores
Score

0.8 0.869 0.867

UtilitySubscores
0.873 0.870
UtilityScore

0.8 0.8 0.869 0.867 0.817


0.8 0.873 0.870 0.794 0.757 0.817
(0.112) (0.170) 0.794 0.757 (0.170) 0.707 0.741 (0.147)
0.6 (0.112) (0.170) 0.6 (0.170) 0.707 0.741 (0.147) (0.206)
0.6 (0.169) 0.6 (0.251) (0.256) (0.206)
(0.169)
TotalUtility

(0.251) (0.202) (0.256)


(0.202)
0.4 0.4
0.4

Utility
0.4
Total

0.2 0.2
0.2 n = 314 n = 246 n = 74 0.2
n = 314 n = 246 n = 74
0.0 0.0
0.0 0.0 Independent Relation- Mental Coping Pain Senses
normal hearing normal hearing CI-users Independent Relation- Mental Coping Pain Senses
normal hearing normal hearing CI-users Living ships Health
norm values norm values from this study Living ships Health
norm values norm values from this study
from Maxwell et al. from Hawthrone et al.
from Maxwell et al. from Hawthrone et al.

(a)
(a) (b)
(b)
Figure 3. Graphical
Figure Graphical representation of of the total
total utility score
score ((a), blue
blue bar)and and the utility
utility sub-scores
Figure 3.3. Graphicalrepresentation
representation ofthe the totalutility
utility score((a),
((a), bluebar)
bar) and thethe utility sub-scores
sub-scores
(b) on the assessment of quality of life questionnaire, which included
(b) on the assessment of quality of life questionnaire, which included six dimensions (AQoL-6D), six dimensions (AQoL-6D),
(b) on the
for cochlear assessment
cochlear implant of
implant (CI)treatedquality of
(CI)treated childrenlife questionnaire,
children (n (n == 74)
74) of
of thiswhich
this study included
studyAn six
An additional dimensions
additional comparison (AQoL-6D),
comparison with with the
the
for
for cochlear
total utility implant
scores on (CI)treated
the AQoL-6D children
using (nnorm
= 74)values
of this ofstudy
peers Anofadditional
the same comparison
age and genderwithwith
the
total utility scores on the AQoL-6D using norm values of peers of the same age and gender with
total
normal
normal utility scores
hearing
hearing on the
isisalso
also shown,AQoL-6D
shown, obtained
obtained usingfrom
from norm values
thestudies
the studiesof of peers
ofMaxwell
Maxwellof the same
etal.
et al. [43]age
[43] ((a),and
((a), dark
dark gender
green)with
green) and
and
Hawthorne
normal hearing
Hawthorne et al.
et al. is[44]
also
[44] ((a), light
((a),shown, green).
obtained
light green). Significance level:
from thelevel:
Significance studies p < 0.05.
p < of The
Maxwell
0.05. mean
The mean et al.values and
[43] and
values correspond-
((a),correspond-
dark green)
ing standard
and
ing standard
Hawthorne deviations
et al. [44]
deviations inin parentheses
parentheses are displayed
((a), light green).
are displayed in the
Significance
in thelevel:
bars. The
bars. The scoresThe
p < scores
0.05. range
rangemean from
from the worst
values
the worst
and
score of 0,
corresponding
score indicating
standard
of 0, indicating no quality
deviations
no quality of life (QoL),
of lifein(QoL), to
parenthesesthe maximum
are displayed
to the maximum score
score of
inof
the1, indicating
1, bars. a
The scores
indicating perfect
range
a perfect generic
from
generic
QoL.worst score of 0, indicating no quality of life (QoL), to the maximum score of 1, indicating a
QoL.
the
perfect generic QoL.
3.2.2. Speech
3.2.2. Speech Spatial
Spatial Qualities
Qualities of of Hearing
Hearing ScaleScale (SSQ12)
(SSQ12)
3.2.2.The
Speech Spatial
results of of theQualities
the SSQ12 of Hearing
SSQ12 questionnaire
questionnaire forScale (SSQ12)
for 79
79 pediatric
pediatric CI CI users
users are
are shown
shown in in Figure
Figure
The results
4. TheThe individual
results ofscores
the on
SSQ12 the speech
questionnaire spatial
for qualities
79 of
pediatric hearing
CI
4. The individual scores on the speech spatial qualities of hearing test are displayed. The userstest
are are displayed.
shown in Figure The 4.
The
totalindividual
total score is
score scores onin
is presented
presented the
in speech
blue.
blue. Thespatial
The resultsqualities
results ranged from
ranged of
fromhearing
00 to testwith
to 10,
10, are displayed.
with 00 correspondingThe total
corresponding to
to
score
the is
worst presented
result andin blue.
10 to The
the results
best. A ranged
maximum from 0
score toof
the worst result and 10 to the best. A maximum score of 10 points would indicate that10,10with 0
points corresponding
would indicate to the
that
worst
thereis
there isresult
no and 10 toto
nolimitation
limitation tothe best. of
quality
quality A maximum
oflife
lifedue
dueto score
tothe of 10 points
thehearing
hearing wouldIn
impairment.
impairment. indicate
In general,
general, thatthe
the there
mean
mean is
no limitation
values in to
Figure quality
4 are of life
representeddue toasthe hearing
crosses, and impairment.
the mean
values in Figure 4 are represented as crosses, and the mean value of the overall score of In general,
value of the the mean
overall values
score of
in
theFigure
SSQ124for are CI
for represented
users is as crosses,
is 6.05
6.05 and highest
(1.63). The
The the mean value
score ofof the(1.63)
6.43 overallwasscore of the SSQ12
achieved in the
the
the SSQ12 CI users (1.63). highest score of 6.43 (1.63) was achieved in
for CI users
qualities of is 6.05
of hearing (1.63).
hearing section. The
section. Hence,highest
Hence, the score
the lowest of 6.43
lowest score, (1.63)
score, 5.79 was
5.79 (2.19), achieved
(2.19), was
was given in the
given for qualities
for the
the speech
speech of
qualities
hearing
category. section. Hence, the lowest score, 5.79 (2.19), was given for the speech category.
category.

5.793
5.793 5.946
5.946 6.434
6.434 6.049
6.049
(2.186)
(2.186) (2.074)
(2.074) (1.631)
(1.631) (1.634)
(1.634)
10
10

88
points
Meanpoints

66
Mean

44

22

00
Speech
Speech Spatial
Spatial Qualities
Qualities Overall
Overall
Figure
Figure 4.Boxplot
Figure 4.
4. Boxplotpresentation
Boxplot presentation
of the
presentation of
Speech
of the
the Spatial
Speech
Speech
Qualities
Spatial
Spatial
of Hearing
Qualities
Qualities
Scale questionnaire
of Hearing
of Hearing (SSQ12)
Scale questionnaire
Scale questionnaire
outcomes from 79 cochlear
(SSQ12) outcomes
outcomes from 79 implant implant
79cochlear
cochlear users. Median and quartiles
users.Median
Median for the sub-scores
and quartiles
quartiles for the and the and
the sub-scores
sub-scores overall
the
(SSQ12) from implant users. and for and the
overall score (blue) are presented. An additional representation of the mean values are
overall score (blue) are presented. An additional representation of the mean values are shown as shown as
J. Pers. Med. 2023, 13, 1610 15 of 21

score (blue) are presented. An additional representation of the mean values are shown as crosses
inside the boxplots and as numerical values above the boxplots, with their standard deviations in
parentheses. The score, in general, ranges from a worst possible score of 0 to an optimal score of 10.
A maximum score of 10 represents no limitations on quality of life due to hearing impairment.

3.2.3. Pure Tone Audiometry


Pure tone audiometry refers to the total number of examined ears which were treated
with a cochlear implant (Table 5). The best aided hearing level was 24.4 dB, measured at
a frequency of 0.25 kHz, as shown in (Figure 5, Table 5). The hearing threshold ranged
from 24.4 dB (2.62 dB), at a test frequency of 0.25 kHz, to 27.3 dB (1.52 dB) at a frequency of
J. Pers. Med. 2023, 13, x FOR PEER REVIEW 14 of 20
6 kHz.

Table 5. Mean values of the hearing thresholds and their standard deviations (SDs) at the specific test
frequencies
deviations of the pure tone
in parentheses. audiometry
The score, for the
in general, cochlear
ranges from aimplant users ofscore
worst possible this study. The
of 0 to an degrees
optimal
score of 10. Aloss
of hearing maximum score
(HL) were of 10 represents
determined by theno limitations
guidelines of on quality Speech-Language-Hearing-
American of life due to hearing im-
pairment.
Association (ASHA) [46].

Frequency
3.2.3. Pure Hearing Threshold,
Tone Audiometry n Degree of Hearing Loss
SD
(kHz) Mean (dB) (Ears) according to ASHA
Pure tone audiometry refers to the total number of examined ears which were treated
0.25
with a cochlear 24.4
implant (Table 2.62 hearing level
5). The best aided 55 was 24.4 dB, Slight HL
measured at a
frequency0.5 26.3 in (Figure 5,3.47
of 0.25 kHz, as shown Table 5). The56hearing threshold
Mild HL from
ranged
24.4 dB (2.62
1 dB), at a test frequency
24.6 of 0.25 4.06
kHz, to 27.3 dB
55 (1.52 dB) at aSlight
frequency
HL of 6
kHz. 2 24.6 2.34 55 Slight HL
The blue area at the bottom of the audiogram represents the cochlear implant indica-
4 26.8 2.21 51 Mild HL
tion range of the manufacturer (MED-EL [45]) (Figure 5). The hearing thresholds of most
6
CI users improved by at least27.3 1.52
40 dB after implantation. 45 Mild HL

Figure 5. Audiogram with averaged hearing thresholds and standard deviations of the children
Figure 5. Audiogram
and adolescents with
with averaged
cochlear hearing
implants thresholds
(CI). For each and standard
frequency, deviations
data of the
from at least 40children
CI usersand
were
adolescents with cochlear implants (CI). For each frequency, data from at least 40 CI users were
considered, but the exact numbers of participants are noted in Table 5. The blue area shows the CI
considered, but the exact numbers of participants are noted in Table 5. The blue area shows the CI
indication range based on the manufacturer’s recommendation [45].
indication range based on the manufacturer’s recommendation [45].
The blue area at the bottom of the audiogram represents the cochlear implant indica-
Table 5. Mean values of the hearing thresholds and their standard deviations (SDs) at the specific
tion range of the manufacturer (MED-EL [45]) (Figure 5). The hearing thresholds of most
test frequencies of the pure tone audiometry for the cochlear implant users of this study. The degrees
CI users improved by at least 40 dB after implantation.
of hearing loss (HL) were determined by the guidelines of American Speech-Language-Hearing-
Association (ASHA) [46].

Frequency Hearing Threshold, Mean n#break# Degree of Hearing Loss according to


SD
(kHz) (dB) (Ears) ASHA
0.25 24.4 2.62 55 Slight HL
J. Pers. Med. 2023, 13, 1610 16 of 21

3.2.4. Speech Audiometry


The HSM sentence test was conducted at a self-help camp in Romania, and 41 children
and adolescents with cochlear implants successfully completed the test which can be seen
in Table 6. Overall, a mean score of 71.6% (23.8) was achieved by the young CI users.

Table 6. Results of the Hochmaier–Schulz–Moser (HSM) sentence test for 41 cochlear implant users.
The scores generally ranged from a minimum score of 0% to a maximum score of 100%, indicating
perfect speech comprehension.

Properties Scores
Participants (n) 41
Mean (%) 71.6
Standard deviation (%) 23.8
Minimum (%) 15.1
Maximum (%) 100

3.2.5. Implantation Timepoint


The study cohort was split into early (≤3 years) and late (>3 years) implantation
groups. The assessed quality of life (AQoL-6D and SSQ12) and audiological (PTA and
HSM sentence test) parameters were compared with each other. No significant differences
between the early and late implantation groups were found for any of the four comparative
parameters (Table 7).

Table 7. Comparative values between early (≤3 years) and late (>3 years) implantation timepoints
for cochlear implant users.

Comparison Early Implantation Late Implantation Significantly Different


n n p-Value
Parameters ≤3 Years >3 Years (p < 0.05)
AQoL-6D 0.78 (0.19) 37 0.81 (0.14) 37 0.7252 No
SSQ12 5.97 (1.79) 41 6.13 (1.47) 38 0.5995 No
PTA 25.6 dB (12.8 dB) 27 21.2 dB (7.01 dB) 20 0.1127 No
HSM sentence
72.9% (24.5%) 22 70.1% (23.5%) 19 0.6283 No
test
The following parameters were compared: Assessment of Quality of Life in six dimensions (AQoL-6D), Speech
Spatial Qualities of Hearing Scale (SSQ12), Pure Tone Average (PTA), and the Hochmair–Schulz–Moser (HSM)
sentence test. The comparison parameters are significantly different when the p-value is <0.05.

3.2.6. Generic and Health-Related Quality of Life


A moderate and significant correlation between the generic (AQoL-6D) and the health-
specific (SSQ12) questionnaires was found, with a Spearman coefficient of 0.4370 [47].
Additionally, the relationship between the utility score of the senses dimension of the
AQoL-6D compared to the SSQ12 was investigated. With a Spearman coefficient of 0.6739,
a moderate and significant correlation was found (Table 8).

Table 8. Correlation characteristics of the total scores of the generic (Assessment of Quality of Life in
six dimensions (AQoL-6D)) and health-related (Speech Spatial Qualities of Hearing Scale (SSQ12))
quality of life. The correlation is significant when the p-value is <0.05.

Spearman Correlation Correlation Significant


Correlation Parameter n Pairs p-Value
ρ Strength (p < 0.05)
AQoL-6D and SSQ12 72 0.4370 moderate 0.0001 Yes
AQoL-6D Senses and SSQ12 72 0.6739 moderate <0.0001 Yes
J. Pers. Med. 2023, 13, 1610 17 of 21

4. Discussion
From the generic QoL results, it can be concluded that CI users can achieve the
same level of quality of life as their healthy, normal-hearing peers. After comparing
the normative values from two different publication populations [43,44], no significant
difference regarding the QoL was detected between normal-hearing and CI-treated children
and adolescents (p < 0.05). Although the absolute numerical norm values achieved by
Hawthorne et al. [44] (0.870 (0.170)) and Maxwell et al. [43] (0.873 (0.112)) were somewhat
different, a multiple comparison method revealed no significant difference in utility scores
compared to the outcomes of this study (0.794 (0.169)), supporting the statement that
CIs increase the QoL of hearing-impaired people after treatment [4] and confirming that
normal hearing standards can be achieved. A possible influence of the fact that some
questionnaires were answered by or together with the parents due to the age of the child
and more heterogenous outcomes, as reflected by a rather high standard deviation (SD)
such as that reported by the study of Khadka et al., could not be seen in our results, which
achieved a rather low SD of 0.169 [48]. The validated norm values were retrieved from age
groups of 15–19 years in the publication by Hawthorne et al. [44] and 16–24 years in the
study of Maxwell et al. [43].
However, the overall positive outcomes are probably the result of an increase in self-
confidence bolstered by the ability to communicate [6]. As no statistical gender differences
could be found, the outcomes were not split (p > 0.05).
A total of 79 participants achieved a mean overall score of 6.05(1.63) for the health/hearing-
related QoL, assessed by the Speech Spatial Qualities of Hearing Scale (SSQ12), which appears
to be rather low in comparison to other publications [49–52]. Emphasis needs to be placed on
the rather young study cohort, in which speech might not have been as developed due to age,
not due to hearing status. It is also possible that the comparative studies simply presented
the results of small, top-performing groups. For example, the studies by Rauch et al. [49] and
Falcon et al. [50] involved single-sided deaf patients with normal hearing on one side [53].
A moderate and significant correlation between the outcomes of the generic and
health/hearing-specific QoL was detected (Table 8). Unsurprising, the AQoL-6D subdi-
mension of senses, which deals with seeing, hearing, and communication, showed the
best correlation with the SSQ12, again reflecting the importance of hearing on overall
quality of life. Parameters like anxiety, feelings of seclusion, or depression, which very
often accompany untreated hearing loss [2], are often evaluated, and may be eliminated
via treatment.
Even though the literature on AQoL assessments in the population with hearing loss is
sparse, the questionnaire was used as the assessment of choice for utilization in the clinical
process. The reasons were as follows: first, access was free of charge; second, the statistical
software SPSS and STATA provided easy and, therefore, bias-free evaluation tools; and
third, the availability of validated population norms enabled statistical comparisons. The
provided data calculation syntax for STATA and SPSS ensures correct data analysis and,
therefore, better comparability. Thus, no random deviations or obvious calculation errors
occurred, as was found in the published outcomes of several HUI 3 questionnaire studies.
The HUI was often evaluated incorrectly, which unfortunately made the results unusable
for our systematic review and comparisons, especially since a license fee was required to
for this questionnaire.
During the review process of the different QoL studies, it became evident that a
consensus on the application of QoL instruments would be advisable.
Unfortunately, not enough comparable data were available to perform a meta-analysis
(Tables 3 and 4) [1,15,16,22–42,54,55]. Although no age group was excluded from the
literature review, it is apparent that there is limited data available regarding QoL surveys
on children [1,38–42]. This was one of the reasons why this study focused on collecting
data from children and adolescents.
In conclusion, the systematic literature review clearly showed improved QoL after
implantation, comparable to that of healthy, normal-hearing children, but also showed some
J. Pers. Med. 2023, 13, 1610 18 of 21

clear limitations: first, a clear classification of health-related and generic QoL questionnaires
is necessary. Second, uniform and correct assessments are needed in order for comparisons
to be made. Third, more day-to-day evidence is required, which points towards the
necessity to implement QoL questionnaires into clinical routines. More data on the QoL of
the pediatric population are especially required.
The 41 tested CI users achieved impressive speech comprehension, with an overall
score of 71.6% (23.8%) on the HSM sentence test (Table 6). The rather high standard
deviation might be because of overly complex sentences or words, even though the HSM
test includes everyday phrases in order to eliminate this possible bias. Another possibility
might be the concentration level or the unfamiliar environment, or that the children were
simply too shy to repeat the words [56].
The tested CI users showed an improvement of around 40 dB with the use of a cochlear
implant, as the mean aided hearing threshold was between 24.4 dB (2.62 dB) and 27.3 dB
(1.52 dB).
The literature repeatedly points out the importance of early implantation to ensure the
optimal developmental effects [57–59]. Our study group outcomes were split into early- and
late-implanted children (Table 7). Children under 3 years of age at the time of implantation
were considered to fall into the early implantation group, and the rest comprised the
late implantation group. Despite the outcomes not being significantly different, the early
implantation group performed about 10% better than the comparison group on the HSM
sentence test.
In conclusion, both age groups achieved generally good results for all measurements
which were undertaken. These great results are probably related to the support of the
families and their social environments. This assumption is based on the fact that all
examinations, as well as rehabilitation and training (in the camp as well as in the hospital
in Timisoara), were voluntary, and the parents went above and beyond to provide their
children with all the opportunities necessary to further improve their hearing. Obviously,
they were doing everything right.

5. Conclusions
Studies investigating the effect of a CI on different aspects of QOL and audiologic
performance are important in order to provide realistic expectations to our patients, espe-
cially when children are involved. This study has proven that cochlear implant users can
achieve the same generic quality of life as their normal-hearing peers. The audiological
examinations showed a clear benefit after cochlear implantation. Since speech comprehen-
sion is challenging, the good outcomes achieved on the HSM sentence test by the CI users
in Romania were impressive. Even though no significant difference was found between
late and early implantation, for the QoL and audiological parameters examined, the early
implantation group exhibited roughly 10% greater speech understanding compared to the
later implantation cohort. No significant correlation between the generic and health-related
quality of life questionnaires was found. Thus, both should be administered to obtain a
better understanding of children and adolescents treated with cochlear implants and their
hearing/health, as well as their general satisfaction in life.

Author Contributions: Conceptualization, H.E.S.; methodology, H.E.S. and G.G.; validation, G.G.,
D.E.T. and H.E.S.; formal analysis, G.G.; investigation, G.G. and D.E.T.; resources, G.G. and D.E.T.;
data curation, G.G. and D.E.T.; writing—original draft preparation, G.G.; writing—review and editing,
all authors; visualization, G.G.; supervision, H.E.S. All authors have read and agreed to the published
version of the manuscript.
Funding: This research received no external funding.
Informed Consent Statement: Informed consent was obtained from all parents and legal guardians
of the subjects involved in the study.
Conflicts of Interest: The authors declare no conflict of interest.
J. Pers. Med. 2023, 13, 1610 19 of 21

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