2023 06 13 23291338v1 Full
2023 06 13 23291338v1 Full
9 Syte Institute
11 Email: [email protected]
12 Tel: +49-40555536224
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15 Abstract
16 Electric stimulation via a Cochlear Implant (CI) enables people with severe to profound
17 sensorineural hearing loss to regain speech understanding and music appreciation and
18 thus allowing them to actively engage in social life. Three main manufacturers
19 (Cochlear, MED-EL and Advanced Bionics “AB”) have been offering CI systems, thus
20 challenging CI recipients and Otolaryngologists with a difficult decision, as currently no
21 comprehensive overview or meta-analyses on performance outcome following CI
22 implantation is available. The main goal of this scoping review is to provide evidence
23 that data and standardized speech and music performance tests are available for
24 performing such comparisons. To this end, a literature search was conducted to find
25 studies that address speech and music outcomes in CI recipients. From a total of 1592
26 papers, 188 paper abstracts were analyzed and 147 articles were found suitable for
27 examination of full text. From which, 42 studies were included for synthesis. A total of
28 16 studies used the consonant-nucleus-consonant (CNC) word recognition test in quiet
29 at 60db SPL. We found that aside from technical comparisons, only very few
30 publications compare speech outcomes across manufacturers of CI systems. Evidence
31 suggests though, that these data are available in large CI centers in Germany and US.
32 Future studies should therefore leverage large data cohorts to perform such
33 comparisons that could provide critical evaluation criteria and assist both CI recipients
34 and Otolaryngologists to make informed performance-based decisions.
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35 1. Introduction
36 Cochlear implants (CI) encompass implanted electronics and external sound processors
37 that can deliver electric stimulation to the auditory nerve and improve hearing in
38 subjects with severe to profound hearing loss. Despite being a well-established
39 intervention for this condition, there is a strong variability in the individual hearing
40 restoration achieved by CI, which may depend on several factors, ranging from device
41 specifications to surgical placement of the implant, as well as patient-specific factors
42 such as age at implantation and duration of hearing loss (Holden et al., 2013). Implant
43 recipients improve their conversational speech understanding following implantation, on
44 average up to 52% (Dunn et al., 2020) and in many cases, improve so significantly that
45 they can understand conversational speech in difficult listening situations (Dorman &
46 Gifford, 2017). Significant improvement in music perception and satisfaction following CI
47 implantation is also observed (Chang, 2021). This has become particularly important as
48 studies showed that quality of musical sound and patients QoL post-implantation were
49 associated significantly. However, CI were initially designed to enhance speech
50 discrimination. In the past 10 years, Fine Structure information has been represented in
51 CI processing strategies to further improve music perception (Lassaletta et al., 2009).
52 Recent estimations suggest that approx. one million cochlear implants have been
53 implanted world-wide (Zeng, 2022). Clearly, a rapid growth in this field can be observed
54 as previous FDA (food and drug administration, USA) reports from 2019 and 2016
55 suggest an approx. of 736K and 324K resp. implanted devices worldwide. A portion of
56 this growth can be attributed to expanding CI candidacy guidelines (Varadarajan et al.,
57 2021). Implantation is now available to a broader group of individuals compared to when
58 implants were first introduced in the 70’s. Individuals are now more commonly implanted
59 with a CI system when they suffer from unilateral deafness (Carlson et al., 2018), or
60 intractable tinnitus (Assouly et al., 2021), and in the presence of increasing amounts of
61 residual hearing (Varadarajan et al., 2020).
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64 expanded. A recent search for cochlear implants on PubMed yielded over 1500 papers
65 in 2021 alone, an increase of almost 600% in the last 20 years (2001: 262 papers).
66 Study topics in peer-review literature range widely, from candidacy guidelines to implant
67 technological features, programming (mapping), rehabilitation, and performance
68 outcomes to name a few.
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92 of these 47 provided any information on device manufacturers. This means that the data
93 needed to compare speech and music performance outcomes between the different
94 devices apparently exist, but comparisons are seldomly made.
95 One outstanding example, dating 15 years back, is a study by Spahr et al. (2007) which
96 investigated patient’s performance in monosyllabic word tests presented in quiet and
97 under different noise levels, comparing CI systems by the three manufacturers
98 (Cochlear, AB and MED-EL). Results showed differences between devices in vowel
99 recognition, and sentence comprehension in noise. In addition, the authors showed that
100 when the input dynamic range was increased, performance measures of all devices
101 improved. A later study by Haumann et al. (2010) compared speech performance in
102 noise under realistic adaptive conditions across five different CI systems (Freedom and
103 Esprit 3G by Cochlear, Auria and Harmony by AB, Opus 2 by MED-EL). Here results
104 showed a clear disadvantage for Freedom (Cochlear) compared to Opus 2 (MED-EL).
105 Other studies have compared specific technical features of these systems (Shader et
106 al., 2020; Sivonen et al., 2020). For example, Killan et al. (2019) assessed the effect of
107 inter implant interval and onset of profound deafness on sound-source localization in
108 children with bilateral cochlear implants from three manufacturers (Cochlear, AB and
109 MED-EL). The authors found that MED-EL devices were associated with significantly
110 better sound-source localization when compared to both Cochlear and AB devices.
111 A recent retrospective study by Sturm et al., (2021), investigated the effect of physical
112 features of CI electrodes including length and shape of the electrode array, as well as
113 its position relative to the cochlear modiolus, on hearing outcomes. Authors recruited
114 119 adult (>18 years) subjects with post-lingual hearing loss, who underwent cochlear
115 implantation with a full electrode array insertion. Seven different electrode arrays from
116 three CI manufacturers (Cochlear, MED-EL, AB) were compared. Speech perception
117 outcomes were measured using the consonant-nucleus-consonant (CNC) word
118 recognition test in quiet, at the same presentation level and fixed test intervals (three,
119 six, 12, and 24-months following implantation). Pre-operative speech scores were
120 similar between electrode array groups and the same surgical approach was used.
121 Given the consistencies in data collection and patient demographics, this study was well
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122 configured for a comparison between the devices. However, the authors chose to
123 compare speech performance without accounting for pre-operative measures of CNC
124 and thus dramatically increased inter-individual variability as well as reduced reliability
125 of device comparisons. In addition to the pre-operative speech perception score,
126 several other factors should have been accounted for such as: (1) The duration of
127 deafness and pre-operative hearing aid used, and (2) the cochlear duct length, insertion
128 angle and electrode position within the cochlea. Lastly, while CNC in quiet may provide
129 some insights on hearing abilities, other speech tests performed in noise and thus
130 assimilating real-life scenarios, are much more suitable for assessing the range of
131 auditory abilities following implantation.
132 A review by Boisvert et al. (2020) further supports the possibility to conduct comparative
133 studies across CI manufacturers. The authors aimed to provide evidence for the efficacy
134 of unilateral cochlear implantation in adults by assessing the procedure’s success rate,
135 based on speech perception or self-reported measures in studies from the last 22 years.
136 The authors found that while measurements, research design and reporting of results
137 were inconsistent, 46 studies used monosyllabic words for post-operative speech
138 perception tests, while 34 studies used sentences in quiet to test for speech perception
139 following CI implantation. In addition, there was some relative consistency with
140 presentation levels of monosyllabic words in quiet, with mostly being 60dB SPL (32% of
141 studies) or 65dB SPL (36% of studies). Such numbers suggest a potential for a
142 meaningful comparison of speech outcomes between devices of different
143 manufacturers.
144 To be able to compare data from existing publications and determine if speech and
145 music performance outcome using a specific CI system is superior, several factors need
146 to be considered. Firstly, it would be important to compare devices of the same
147 generation. As CI technology advances, patient performance improves (Krueger et al.,
148 2008). Therefore, a comparison of outcomes with the latest technology to previous
149 generation devices is not sensible. Another consideration is the test conditions. Ideally,
150 identical conditions are necessary to systematically compare performance outcomes.
151 Evaluation tools, presentation levels, signal to noise ratios, language and test intervals
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152 would need to be similar if not identical to be able to perform meaningful comparisons
153 (Adunka et al., 2018). Lastly, subject demographics must be considered. Duration of
154 deafness, prior use of amplification, pre-operative pure tone thresholds (PTA), and
155 certain etiologies are all known factors that may impact speech performance following
156 implantation (Ahmed Elkayal et al., 2016). Finally, similar patient profiles would be
157 important in isolating the effect of the CI system in driving outcome differences and
158 therefore allow optimal comparison between CI systems of different manufacturers.
159 The main goal of this scoping review is to identify a research gap in comparisons of
160 speech and music perception outcomes following CI implantation across different
161 manufacturers. Manufacturer comparisons focused on outcomes are of crucial
162 importance for clinicians, CI candidates and manufacturers. Such comparisons could be
163 an important, more straightforward, and reliable source for decision-making processes,
164 when compared to various technical device features that differ between CI systems3. CI
165 manufacturers could benefit from this transparency by better understanding the effect of
166 technological advancements on patient outcomes and factor these key learnings into
167 future developments. Evidence suggests that more competitive markets within the
168 healthcare industry, lead to increased quality of product features (Medicine et al., 2010).
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www.cochlearimplanthelp.com
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169 2. Methods
170 A scoping review methodology was chosen to evaluate whether speech and music
171 perception outcomes in adult CI users could be compared between manufacturers. A
172 scoping review is ideal for answering these types of questions, by providing a coverage
173 of a body of literature on a given topic, thus giving a clear indication of the availability of
174 studies (Munn et al., 2018). We applied the population, concept, context (PCC)
175 framework recommended for scoping reviews which guided the protocol listed below.
176 The population is hearing impaired adults who underwent implantation of CI system.
177 The concept of the scoping review is speech and music perception outcomes, and the
178 context is defined to be the availability of CI manufacturer information.
179
180 2.1 Search strategies
181 A literature search was conducted using both PubMed database and Google Scholar
182 search engine, thus covering a broad literature source for the field of Cochlear Implants.
183 We used the key words “Cochlear implant outcomes adults” (S1) as well as “Cochlear
184 implant music adults” (S2) in March 2022. The review protocol was not pre-registered.
185 An initial search found that Google Scholar showed less relevant publication titles when
186 compared to PubMed and the publications found in the former matched those found on
187 PubMed. In addition, we searched the clinicaltrials.gov database, which provides
188 information on funded clinical trials around the world, with the search term: “Cochlear
189 Implant” (S3) in March 2022. We cross-checked the findings with the first 200 papers on
190 Google Scholar. Fig. 1 describes our screening procedure.
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197 commentary articles, case-studies and meta-analyses as these do not contain detailed
198 information required for our scoping review (mainly speech and music perception scores
199 and manufacturer information). Next, the abstracts of all remaining studies (S1 = 177,
200 S2 = 11) were analyzed independently and charted in Excel (© MS Office). The authors
201 applied the following exclusion criteria to the remaining studies through a mutual
202 discussion.
211 Studies focusing on predicting factors that influence performance outcome such
212 as: genetics, fatigue, subject self-reports, candidacy, robotics, telemedicine,
213 auditory training, surgical approaches, reimplantation, surgical complications, or
214 revision surgery. These studies were excluded to eliminate the inclusion of very
215 specific populations that may differentially affect performance which and are not
216 representative of the CI community. Longitudinal studies were excluded as they
217 include previous generation devices. Comparison of CI performance with other
218 technologies (hearing aids, bone conduction implants). Drug therapies provided
219 in addition to implantation. Objective measures not accompanied by speech
220 scores. Listening effort or hearing preservation as a primary outcome measure.
221 Following this exclusion, a total of N = 147 (S1 = 136, S2 = 11) publications were found
222 suitable for further analysis and an examination of the full text. We then additionally
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223 excluded studies with number of subjects lower than eight and primary measures that
224 were not speech or music performance. Following this in-depth review of studies, we
225 found 42 publications that we included in the final overview table (see supplementary
226 materials).
227
228 2.3 Data charting process
229
230 A data-charting form was created in Excel by two reviewers (AK, ETM). Variables to be
231 extracted from the studies were determined by all authors. Data was extracted as
232 reported in the text or the figures. Study authors were not contacted when study
233 information was unclear or not reported. Data charting categories included general
234 information such as the publication title, authors name, institution in which data was
235 collected, year and journal of publication. In addition, device-specific information was
236 collected such as device type and launch date as well as manufacturer information.
237 Note that no studies with bi-branded CI recipients were included. Study characteristics
238 such as the number of participants included in the study, age range, gender, as well as
239 pre-operative parameters such as pure tone average (PTA), and duration of hearing
240 loss were recorded. Importantly, we charted detailed information on the specific post-
241 operative speech or music performance test, including test conditions, such as whether
242 it was performed in noise or not as well as test interval following CI implantation.
243
244 2.4 Synthesis of results
245 We mapped the findings based on the following criteria: (1) study characteristics,
246 including publication year and journal, (2) manufacturer information and launch data (3)
247 speech tests, (3) speech test conditions, (4) music performance, (5) number of subjects
248 (histogram). Analysis of speech perception outcomes focused on the most used test:
249 CNC word recognition. The data from six studies that used CNC words presented at
250 60dB SPL in quiet were further compared. Three of these studies reported on devices
251 manufactured by Cochlear, and three on devices manufactured by MED-EL. To account
252 for the different number of participants in each study included in this analysis, we
253 performed a weighted averaging of the scores by the number of participants. We
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254 synthesized the results for different intervals including 1-month, 3-month, 6-month and
255 12-month following implant operation.
256 3. Results
257
258 3.1 Study Characteristics
259 The 42 studies included are detailed in the supplementary materials. In Fig. 2, we show
260 the distribution of studies across 2015 - 2021. Most studies were published in 2020 (N =
261 9) and a relatively low number of studies were published in 2017 (N = 3) and 2021 (N =
262 4).
263
264 The distribution of journals used to publish speech and music perception outcomes for
265 CI is depicted in Fig 3. Most studies were published in Otology & Neurotology (N = 9)
266 followed by Cochlear Implants International (N = 6). Only three studies were published
267 in JAMA Otolaryngol Head Neck Surg.
268
269 3.2 CI system manufacturer information
270 Only two studies out of 42 did not mention any information regarding the manufacturer
271 of the CI systems used in the study. From the remaining 40, five studies did not mention
272 any information on the specific model of the CI system. The distribution of studies
273 mentioning specific CI systems is shown in Fig. 4. Most studies mention Cochlear as a
274 manufacturer for the CI systems implanted in the included cohort (N = 24). MED-EL is
275 mentioned by 19 studies, AB by 12, and Oticon by three. Five studies mentioned three
276 manufacturers, and 5 studies mentioned two manufacturers.
277
278 3.3 CI systems launch date
279 Of the studies mentioning the manufacturer, we noted the device types to compare the
280 date of paper publication with the novelty of the device technology. Only 24 studies (of
281 42, 57%) mentioned the device type. On average, CI systems were seven years old
282 when the study was published. For studies including different manufacturers, the
283 differences in launch dates were as much as 23 years (e.g., Fuller et al. 2021). Thus,
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315
316 Pre-operative characteristics
317 Age. Mean or median age at implantation was reported in 83% of the studies (35 out of
318 42). Two studies reported only the age range. The mean age across articles was
319 56.8±9.9. The median was 59 (min: 25, max: 74). The distribution of mean/median age
320 across studies is shown in Fig. 6.
321
322 Etiology. The articles included in this review only reported on adults with postlingual
323 hearing loss as per the exclusion criteria. Only 50% of the studies reported the etiology
324 of hearing loss in the investigated cohort. Notably in all studies unknown etiology was
325 also reported, these accounted in average for 46.9% of the patients. In Fig. 7, we show
326 the number of studies per each etiology in the other 50%. Most studies mentioned a
327 genetic/familial cause (N = 13). Next, Meningitis, Head trauma, Ototoxicity and
328 Meniere’s disease were mentioned in 6-8 studies. Measles appeared in two studies
329 only.
330
331 Duration of hearing loss. Only postlingual hearing loss was included in this scoping
332 review. Results were obtained for each affected ear and not for a bilateral condition.
333 Twenty out of 42 studies reported the duration of hearing loss or of deafness prior to
334 implantation. Specifically, eight studies reported the duration of deafness, from which
335 four reported the average (22.8, 3.2, 2.6, and 3.6) and three reported the range (0.3-41,
336 0.3-10, 1-6) of years with deafness prior to implantation across subjects. Twelve studies
337 reported duration of hearing loss, from which, three studies reported the range in years
338 of hearing loss across subjects (1-28, <10, <20) and nine studies reported the average
339 in years of hearing loss across subjects (across studies: 22.2±8.7).
340
341 Hearing loss severity. Pre-operative average pure-tone detection was reported in 16
342 out of 42 studies in various forms, either directly stating in the text the average PTA or
343 by supplying a pure-tone audiometric graphic from which we estimated the PTA at
344 three-frequency (0.5, 1, 2 kHz) average. Note that depending on the graphic resolution,
345 these values were not always accurate. Across these studies, we found that the
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377 performed with CI systems by Cochlear and three studies with CI systems by MED-EL.
378 In Table 1, we summarize the results reported for CNC in quiet in the respective
379 studies. Note that some studies did not report the values directly in the text, and these
380 needed to be extracted from the graphics, hence some small inaccuracies should be
381 expected.
382
383 Table 1: Overview of publications that collected CNC word scores at a presentation
384 level 60dB SPL in quiet.
Paper Manufactu Study location N- 1-mo 3-mo 6-mo 12-mo
rer subjects
385
386 To account for the different number of participants in each study we performed a
387 weighted averaging of the scores by the number of participants (see Table 2). We
388 synthesized the results for different intervals including 1-month, 3-month, 6-month and
389 12-month following implant operation. Note that it was not possible to perform a meta-
390 analysis of effect sizes in those studies, as some (Dillon, Buchmann, Buss, Canfarotta)
391 did not report the necessary parameters (standard deviations – STD, standard errors of
392 the mean - SEM). Notably, the results suggest that the differences between the CI-
393 systems in terms of speech outcomes in quiet are negligible. Again, differences may
394 exist when noisy or adaptive conditions are tested but data were not available to make
395 such comparisons.
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396
397
398
399
400 Table 2: Weighted averaging of speech scores across manufacturers
1-Mo 3-Mo 6-Mo 12-Mo
MED-EL 42.6% 48.3% 60.1% 58.5%
Cochlear - 54.1% 59.7% 62.8%
401
402 4. Discussion
403 In this scoping review, we analyzed the literature for recent studies (2015 - 2022)
404 reporting speech and music performance outcomes in adults implanted with a CI
405 system. Our aim was: (1) to map the literature of speech and music performance
406 outcomes and (2) to find whether studies perform outcome comparisons between
407 devices of different manufacturers. Our findings show that very few publications directly
408 compared patient performance outcomes between manufacturers of CI systems. Similar
409 findings were recently reported by Stucke et al.4 for a limited selection of medical
410 devices. CI device comparisons of different manufacturers are rare not only within an
411 implant center but also across centers.
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421 there was no consistency in the level of the noise used. Some centers report using a
422 +10 SNR, others a +5 SNR and a majority used some combination of the two. As with
423 pre-operative assessment for candidacy, a lack of consistency is seen when measuring
424 post-operative outcomes.
446 Another example that data and methods are available to perform comparisons is a
447 study conducted by Kurz et al., (2019) in Wurzburg, Germany. In a retrospective data
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implants
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datenerhebung-mit-logo-05-05-21.pdf
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448 analysis of 55 subjects, the Freiburger Numbers, Freiburger Monosyllable and HSM
449 sentences were examined at one, three, six and 12 months, as well as at yearly follow-
450 up appointments. Similar to the Kiel study mentioned above, the number of implants
451 was too low to compare between manufacturers, as they had only six subjects with
452 either a Cochlear or AB device. Nonetheless, the presence of such data demonstrates
453 that comparisons between device manufacturers are possible.
454 In the 42 publications that survived our selection criteria, we found that the vast majority
455 mentioned the specific CI system manufacturer and 88% of those studies also mention
456 the specific device used. In addition, we found six publications with >70 subjects, and
457 one study included a sample of 150 subjects. With such large cohorts, inter-individual
458 variability as well as other factors influencing performance may play a less significant
459 role when averaging speech performance outcomes. Notably, sample sizes strongly
460 varied between studies. We provided a power analysis for the comparison between CI
461 systems of different manufacturers that assessed the minimum number of subjects
462 required to perform meaningful manufacturer comparisons to be 42, when considering
463 between-group comparisons.
464 In terms of outcome assessment, we found that most studies used speech performance
465 tests to assess the beneficial effect of CI systems. Several studies have also used
466 music performance tests to assess performance outcome following implantation. There
467 was a strong variability in tests used to quantify speech and music performance post-
468 operatively. Nonetheless, we identified 16 studies that used the CNC test under
469 different conditions. From which, six studies that were conducted in the USA, which
470 means that all subjects were English speakers, used similar CNC test conditions: non-
471 adaptive 60dB SPL in quiet. This allowed us to perform a weighted average of CNC
472 outcomes for different time intervals following implantation across the six studies. Note
473 that summarizing the data across studies using effect-sizes was not possible since
474 some of the studies did not report standard deviations or standard errors, which simply
475 does not withstand good scientific practice. Notably, three studies featured MED-EL
476 devices and three studies featured CI systems by Cochlear. The differences found were
477 rather negligible and inconsistent, thus no statements could be made regarding
478 superiority of one specific device. Although CNC in quiet is most commonly used in the
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479 studies reported here, sentence tests such as in AzBio are a better reflection of speech
480 performance in real-life scenarios. However, as the words in the sentence are
481 associated with each other, it is impossible to detach the effect of context on hearing
482 ability (Gertjan Dingemanse & Goedegebure, 2019). In addition, the quiet condition is
483 not valuable, since a far more important outcome is comprehension of speech in noise
484 conditions. Unfortunately, studies implementing sentence tests (examples) in noise,
485 varied significantly in terms of the specific test conditions, thus not allowing cross-
486 studies comparisons. Optimally, post-operative comparisons between devices should
487 be performed within one CI center. As stated above, there is evidence that CI centers in
488 Germany routinely perform the Freiburger test post-operatively, at different time
489 intervals. These data could be leveraged to fill the knowledge gap in terms of reliable
490 manufacturer comparisons. Note however that we found only three studies that used
491 the Freiburg test, probably as most reports on the Freiburg test are from German CI
492 centers and in German and we excluded non-English journals.
493 Notably, in terms of music performance, we found extreme inconsistencies between
494 studies: of the nine studies identified for in depth review, no two studies used the same
495 test to assess outcomes. Some of the parameters tested were often similar but not
496 identical to those in standardized tests such as MuSIC (Drennan et al., 2015; Drennan
497 & Rubinstein, 2008; Gfeller et al., 2006). As for speech perception tests, music
498 perception tests vary in various features. This prohibited us from performing any kind of
499 summary analysis on these outcomes. Notably, music tests to assess outcomes of CI
500 implantation are relatively new and not anchored in any reimbursement regulation and
501 therefore are less reported and less consistent. As music performance is a significant
502 measure that strongly affects patients' quality of life (Dritsakis et al., 2017; Lassaletta et
503 al., 2007), we urge future studies to follow a validated music test in future investigations.
504 It would also be important to investigate how cultural differences affect CI users’ ability
505 to perceive music. Indeed, previous studies could link between cultural aspects and
506 different music perception parameters such as pitch discrimination, melody and rhythm
507 (Wong et al., 2012; Zhang et al., 2020). These findings could assist with future collation
508 of data across different CI centers around the world as well as guide CI manufacturers
509 in adaptation of CI technology to achieve optimal music performance.
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510 We tried to map the reasons regarding feasibility of comparative studies between CI
511 systems of different manufacturers. Firstly, it would be important to compare
512 technologies of the same generations. Large implant centers have patients using
513 multiple generation devices which could make comparisons difficult. Secondly and as
514 stated above, many subjects would be required to better control for inter-individual
515 variability. Small to medium size centers may not have enough subjects to draw a
516 comparison. Thirdly, and specifically related to cross-center comparisons, the
517 evaluation measures, presentation levels, signal to noise ratios, test intervals and test
518 language need to be consistent to make a valid comparison. In a retrospective study
519 design, it is understandable that finding such consistency across centers is challenging.
520 A prospective study would be easier to design but would also have its own challenges.
521 Centers would need to implant the same generation technologies, match the subjects
522 for age, duration of deafness or hearing loss and duration of implant use. Data
523 collection would likely take several years to draw conclusive findings. Additionally, some
524 patient related parameters that would be important to consider when comparing
525 outcomes were either not reported or varied between studies. Long durations of
526 deafness and certain etiologies are such examples that are associated with poorer
527 outcomes and therefore should either be part of the exclusion criteria or matched pairs
528 should be considered as they do not reflect the average population.
529
530 Although direct comparisons between manufacturers are scarce, we did find
531 publications reporting performance outcomes in large numbers of subjects implanted
532 with the same device. In these studies, data collection was very consistent and
533 systematic. Patients were tested at defined test intervals using specific evaluation
534 measures at the same presentation level and SNR. Potentially, large CI centers
535 implanting sufficient number of devices (see power analysis above) from different
536 manufactures could conduct retrospective comparisons using available data.
537 Alternatively, if Center A with a large cohort reported on outcomes with device X and
538 Center B, with an equally large cohort, reported on outcomes with device Y, a
539 comparison between device outcomes could be made. Probably the most valid
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medRxiv preprint doi: https://doi.org/10.1101/2023.06.13.23291338; this version posted June 13, 2023. The copyright holder for this preprint
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547 Some limitations of this scoping review need to be mentioned. First, we used specific
548 search terms “Cochlear implant outcomes adults” and “Cochlear implant music adults”
549 which may have impacted the extent of studies found. Note however that an initial
550 search with different terms have yielded similar results. The exclusion criteria for both
551 patient indications and study types as well as publication language (English) may have
552 also limited the number of publications available for review. Lastly, we restricted our
553 search to recent publications from 2015 to be able to compare results of users with
554 current generation technology. Reviewing literature published prior to 2015 would have
555 produced more outcomes measures for comparison but with outdated technology.
556
557 Conclusions
558 We found very few publications that compared speech and music outcomes across
559 manufacturers. Performance data of different studies cannot be compared between
560 manufacturers for various reasons, most notably being the variability in assessment
561 measures and test conditions, as well as reporting bias. We argue that it is possible,
562 however, to perform such quantitative comparisons. Data to do so should already exist
563 at least in large CI centers in Germany and the USA but analyzes are not published
564 despite the strong need by CI recipients and medical professionals. We therefore urge
565 the community to make these data available. Future efforts should focus on forming a
566 consensus regarding a systematic method of collecting outcome data following CI
567 implantation which will serve clinicians and prospective CI recipients with performance-
568 based comparisons between different CI systems and lead to an informed decision-
569 making. In addition, this information could drive innovation in device design as well as
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570 future developments of CI systems that are focused on the patient’s experience. Lastly,
571 systematically collected data could provide predictive information for clinicians regarding
572 performance outcomes.
573 Acknowledgments
574 This study did not receive any funding. The authors state no conflict of interest. Syte
575 Institute received financial compensation for consultation to Cochlear and MED-EL in
576 the past.
581
582 Figure Captions
583 Figure 1. Literature Inclusion Flowchart
584 Figure 2. Number of studies published per year from 2015 to 2021
585 Figure 3. Distribution of Journals for the analyzed studies
586 Figure 4. Blue bars show the number of studies identified for each CI manufacturer and
587 when 2 or 3 manufactures were mentioned. The red bars show the proportion of studies
588 of multiple manufactures mentioning a specific one.
589 Figure 5. Distribution of the number of subjects with respect to the number of reviewed
590 studies. Note that the outlier 2247 was removed for better visualization.
591 Figure 6. Mean/Median age distribution with respect to the number of reviewed studies
592 Figure 7. Distribution of etiologies with respect to the number of reviewed studies.
593 Figure 8. Distribution of speech tests with respect to the number of reviewed studies
594
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