Peer Review History

Original SubmissionApril 15, 2025
Decision Letter - Renato S. Melo, Editor

Dear Dr. Baumann,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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We look forward to receiving your revised manuscript.

Kind regards,

Renato S. Melo, PhD

Academic Editor

PLOS ONE

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This study was funded by MED-EL Elektromedizinische Geräte G.m.b.H.

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6. We note you have included a table to which you do not refer in the text of your manuscript. Please ensure that you refer to Table 3 in your text; if accepted, production will need this reference to link the reader to the Table.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Yes

Reviewer #2: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

Reviewer #2: Yes

**********

Reviewer #1: This is a well-executed study with strong real-world applicability. Minor refinements, such as enhancing clarity, statistical nuance, and comparative context, could further elevate its impact for clinicians, policymakers, and CI manufacturers. Below is a detailed review with strengths, areas for improvement, and suggestions for refinement.

1. Abstract & Plain Language Summary

•Abstract:

oConsider adding effect sizes (e.g., mean improvement in speech scores) for greater impact.

oClarify if bilateral vs. unilateral users showed differential outcomes.

•Plain Language Summary:

oSimplify technical terms (e.g., "Freiburg tests" → "speech understanding tests").

o Emphasize why registries matter (e.g., "larger datasets lead to better treatment guidelines").

2. Introduction

•Contextualize the SONNET 2 (EAS):

o Briefly explain how it differs from previous models (e.g., SONNET 1) to justify its evaluation.

•Registry Rationale:

o Strengthen the argument for Germany-specific data (e.g., how this complements other EU registries).

3. Methods

•Data Collection:

o Clarify how missing data (e.g., post-op tests) was handled statistically.

o Justify Mann-Whitney U tests for non-normal distributions (add Shapiro-Wilk test results if available).

•Subgroup Analysis:

oElectrode arrays (FLEX28, FLEXSOFT, etc.) had small samples—note if results are exploratory.

4. Results

•Speech Tests:

o Ceiling Effect: The FNum test’s simplicity (high post-op scores) may limit sensitivity—discuss implications.

o Electrode Variability: FLEXSOFT users had lower FMS scores (43.3%) vs. FLEX28 (62.1%). Is this clinically significant?

•HISQUI19:

o Highlight variability in self-reported benefit (Fig. 5). Could pre-existing contralateral CIs explain this?

5. Discussion

•Registry Challenges:

o Expand on solutions for data homogeneity (e.g., centralized training for clinics).

o Compare MEHS vs. other CI registries (e.g., Cochlear’s registry) to highlight best practices.

•SONNET 2 (EAS) Performance:

o Contrast with competitor devices (e.g., Cochlear’s Nucleus, AB’s Marvel) if literature permits.

6. Language & Flow

•Avoid Redundancy:

oThe Plain Language Summary and Introduction overlap—consider merging or trimming.

•Active Voice:

o E.g., "We observed" → "Our analysis showed" for conciseness.

Reviewer #2: The study is a prospective, multicenter registry of patient outcomes for CI users of all ages has been developed. This study highlights the use of the MED-EL Hearing Solutions (MEHS) registry, with the primary aims of; facilitating consistent and reliable cross-cultural data collection across all age groups via an electronic platform, and gathering extensive longitudinal datasets to provide evidence of device effectiveness. The secondary aim of this investigation was to collect routine clinical data on the performance, effectiveness, and safety of the SONNET 2 and SONNET 2 EAS audio processors. Five clinics in Germany (Munich, Oldenburg, Frankfurt, Heidelberg, and Bochum) until 31st May 2023, participated in this analysis.

Overall, it is a well-thought out and executed research manuscript capable of contributing to the body of knowledge especially due to its ample sample size (426 ears, 57 bilateral users). However, I have the following observations,

1. Introduction: Some of the refences appear to have some typo. Looking at Pg 4, Line 105-107 for example, Olusanva & Newton, 2007 appears wrongly spelt when compared with the correct reference in literature.

2. Methods: The statement made in the methodology section Pg 9, Line 105-107, ‘Device deficiencies were classified based on the severity of the issues to the device and its potential impact on patients’ safety’ appears difficult to validate especially in patient’s not currently on admission. Hence relying on patient- reported results to validate clinical safety status might not be accurate.

The reported findings of ‘17 minor clinical events were reported in subjects using the SONNET 2 (EAS) audio processor’ being self-reported, may not be correctly termed as being, no new/unresolved safety concerns reported.

3. The phrasing of the language used in the entire document could benefit from a more professional grammatical input.

4. I found the title, study design, referencing, statistics, figures and tables quite satisfactory.

**********

what does this mean? ). If published, this will include your full peer review and any attached files.

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Reviewer #1: No

Reviewer #2: Yes:  Stephen O Adebola

**********

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Revision 1

Editor

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf

& https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

We have reformatted the manuscript to conform with PLOS ONE’s style requirements. Please note, we did not use track changes for this (because the changes would be overwhelming & do not affect intellectual content).

2. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match.

When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section.

There are no grant numbers.

3. Thank you for stating the following financial disclosure:

This study was funded by MED-EL Elektromedizinische Geräte G.m.b.H.

Please state what role the funders took in the study. If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."

If this statement is not correct you must amend it as needed.

Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf.

We have added

“The funders assisted in study design, data collection and analysis, and preparation of the manuscript. Decision to publish was a joint decision between all authors.”

to the cover letter & to the Funding Sources section at the end of the manuscript.

4. We note that your Data Availability Statement is currently as follows: All relevant data are within the manuscript and its Supporting Information files.

Please confirm at this time whether or not your submission contains all raw data required to replicate the results of your study. Authors must share the “minimal data set” for their submission. PLOS defines the minimal data set to consist of the data required to replicate all study findings reported in the article, as well as related metadata and methods (https://journals.plos.org/plosone/s/data-availability#loc-minimal-data-set-definition).

For example, authors should submit the following data:

- The values behind the means, standard deviations and other measures reported;

- The values used to build graphs;

- The points extracted from images for analysis.

Authors do not need to submit their entire data set if only a portion of the data was used in the reported study.

If your submission does not contain these data, please either upload them as Supporting Information files or deposit them to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. For a list of recommended repositories, please see https://journals.plos.org/plosone/s/recommended-repositories.

If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially sensitive information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. If data are owned by a third party, please indicate how others may request data access.

We have included raw data for 1) the values behind the means, standard deviations and other measures reported & 2) the values used to build graphs.

“The points extracted from images for analysis.” is not relevant in this manuscript.

5. Please remove all personal information, ensure that the data shared are in accordance with participant consent, and re-upload a fully anonymized data set.

Note: spreadsheet columns with personal information must be removed and not hidden as all hidden columns will appear in the published file.

Additional guidance on preparing raw data for publication can be found in our Data Policy (https://journals.plos.org/plosone/s/data-availability#loc-human-research-participant-data-and-other-sensitive-data) and in the following article: http://www.bmj.com/content/340/bmj.c181.long.

Data are anonymized at the source.

6. We note you have included a table to which you do not refer in the text of your manuscript. Please ensure that you refer to Table 3 in your text; if accepted, production will need this reference to link the reader to the Table.

Table 3 is referred to twice in the section “Freiburger monosyllabic speech test” & in the section “Freiburger number test”

Additionally, please note that we have corrected the descriptive results to median and IQR. When the n was 3 or lower, maximum and minimum scores are given. Please see lines appx 182-186.

NEXT PAGE – REVIEWER 1

REVIEWER 1

Reviewer #1: This is a well-executed study with strong real-world applicability. Minor refinements, such as enhancing clarity, statistical nuance, and comparative context, could further elevate its impact for clinicians, policymakers, and CI manufacturers. Below is a detailed review with strengths, areas for improvement, and suggestions for refinement.

Abstract & Plain Language Summary

1. Abstract

a. Consider adding effect sizes (e.g., mean improvement in speech scores) for greater impact.

The median scores at pre-op and 1 yr post-op have been added. We would prefer to not add the interquartile scores but we think it would be more information than necessary for an abstract and would be the text less readable.

b. Clarify if bilateral vs. unilateral users showed differential outcomes.

This was out of the scope of the study and was therefore not assessed, although it could certainly be a topic for a future study.

In addition, we excluded binaural tests to focus on the implant (binaural would also include bimodal tests).

2. Plain Language Summary

a. Simplify technical terms (e.g., "Freiburg tests" → "speech understanding tests").

Could you please give an example? Freiburg tests are not mentioned in the PLS. We could not find other technical terms that would likely be not understood by ENTs.

b. Emphasize why registries matter (e.g., "larger datasets lead to better treatment guidelines").

A sentence to this end has been added.

3. Introduction

a. Contextualize the SONNET 2 (EAS):

i. Briefly explain how it differs from previous models (e.g., SONNET 1) to justify its evaluation.

We added a new section in the Methods (lines 76-83) to briefly describe how the SONNET 2 differs from previous models. We put it in the Methods because we would like the Introduction to focus on registries and their potential.

b. Registry Rationale:

i. Strengthen the argument for Germany-specific data (e.g., how this complements other EU registries)

We added this in the Discussion, where we mention registries in other countries (appx lines 319-324). The reason MED-EL established the MEHS registry is that it does not have access to the German DCIR registry, as per their policy.

4. Methods

a. Data Collection:

i. Clarify how missing data (e.g., post-op tests) was handled statistically.

ii. Justify Mann-Whitney U tests for non-normal distributions (add Shapiro-Wilk test results if available).

The above 2 comments have been addressed in the “Statistical analysis” section (lines appx 181-185).

b. Subgroup Analysis:

i. Electrode arrays (FLEX28, FLEXSOFT, etc.) had small samples—note if results are exploratory.

This is addressed in the Results “Freiburg monosyllabic speech test” (line appx 230) where we state that inferential statistics could only be applied for the FLEX28. Results for the other arrays are presented descriptively. We added “inferential” to make this clearer. That FLEX28 had a higher n than other arrays no doubt reflects real life usage in Germany. In countries, one might expect a higher use shorter arrays due to more cases of cochlear malformation.

5. Results

a. Speech Tests:

i. Ceiling Effect: The FNum test’s simplicity (high post-op scores) may limit sensitivity—discuss implications.

We now state in the Discussion section (appx. Iines 430-2) that the FNum is probably too easy for CI users and so using a more difficult test would be helpful. The FNum test is nonetheless helpful because the standard OLSA test cannot usually be used at preOP.

ii. Electrode Variability: FLEXSOFT users had lower FMS scores (43.3%) vs. FLEX28 (62.1%). Is this clinically significant?

We would need to have a larger sample size for FLEXSOFT to compare these two electrode arrays. Sample size was also the reason why only FLEX28 was tested with inferential statistics.

b. HISQUI19:

i. Highlight variability in self-reported benefit (Fig. 5). Could pre-existing contralateral CIs explain this?

We address this in lines appx. 391-93.

6. Discussion

a. Registry Challenges

i. Expand on solutions for data homogeneity (e.g., centralized training for clinics)

We expanded on this in lines appx 385-90. The introduction of the Weißbuch should help with homogeneity. Additionally, using the CI-ICF (Andries et al., in the references) would help but as the data are derived from each clinic’s routine, improving homogeneity is certainly a challenge. The authors will be discussing this together in the near future.

ii. Compare MEHS vs. other CI registries (e.g., Cochlear’s registry) to highlight best practices.

We have added a paragraph to address this, please see lines appx 338-366.

b. SONNET 2 (EAS) Performance:

i. Contrast with competitor devices (e.g., Cochlear’s Nucleus, AB’s Marvel) if literature permits.

Direct comparisons between cochlear implant systems from different manufacturers—such as MED-EL’s SONNET 2, Cochlear’s Nucleus series, or Advanced Bionics’ Marvel platform—are limited in the literature due to variability in clinical protocols, patient populations, and outcome measures. Most published studies avoid head-to-head comparisons, recognizing the challenges of establishing equivalency across diverse technological ecosystems and proprietary algorithms. Furthermore, for an equal comparison, we would probably need to compare two sets of real-world evidence.

As for registries, the papers we can find from Cochlear’s IROS (and P-IROS) registry assess specific patient groups (i.e., children in the P-IROS) or specifically focus on patient-reported outcomes measures, so aren’t comparable to the present study.

We’ve added information to this effect to the Discussion. See lines appx 333-336.

c. Language & Flow

i. Avoid Redundancy:

1. The Plain Language Summary and Introduction overlap—consider merging or trimming.

This is intentional because the Plain Language Summary and the Introduction are for different audiences so are independent of each other.

ii. Active Voice:

1. E.g., "We observed" → "Our analysis showed" for conciseness.

Each instance of “we observed” has been edited out.

NEXT PAGE REVIEWER 2

REVIEWER 2

Overall, it is a well-thought out and executed research manuscript capable of contributing to the body of knowledge especially due to its ample sample size (426 ears, 57 bilateral users).

However, I have the following observations,

1. Introduction: Some of the refences appear to have some typo. Looking at Pg 4, Line 105-107 for example, Olusanva & Newton, 2007 appears wrongly spelt when compared with the correct reference in literature.

This has been corrected in the Introduction (correct spelling Olusanya). We could not find other references that have typos. All have been reformatted as per PLOSOne requirements.

2. Methods: The statement made in the methodology section Pg 9, Line 105-107, ‘Device deficiencies were classified based on the severity of the issues to the device and its potential impact on patients’ safety’ appears difficult to validate especially in patient’s not currently on admission. Hence relying on patient- reported results to validate clinical safety status might not be accurate.

We have added a sentence to the end of the “Safety” section to address this, see lines appx 113-5.

The reported findings of ‘17 minor clinical events were reported in subjects using the SONNET 2 (EAS) audio processor’ being self-reported, may not be correctly termed as being, no new/unresolved safety concerns reported.

This sentence in the Abstract has been changed to “Safety was assessed as per participant self-report: 17 minor clinical events were reported, none were new or unresolved”

3. The phrasing of the language used in the entire document could benefit from a more professional grammatical input.

All content in the document re-edited and reviewed by a native English speaker and professional medical writer.

Attachments
Attachment
Submitted filename: Response to reviewers round 1.docx
Decision Letter - Andreas Buechner, Editor

MED-EL Hearing Solution Registry: An examination of the strengths and limitations of a cochlear implant registry

PONE-D-25-18559R1

Dear Dr. Baumann,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Andreas Buechner

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions??>

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

Reviewer #2: Yes

**********

Reviewer #1: Your manuscript is well-structured, Well-defined and appropriate statistical controls. It worse publications

Reviewer #2: Found the responses to the observations made to be acceptable and would recommend the manuscript be accepted in current format

**********

what does this mean? ). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy

Reviewer #1: Yes:  Mohammed Elrabie Ahmed

Reviewer #2: Yes:  Adebola, Stephen Oluwatosin

**********

Formally Accepted
Acceptance Letter - Andreas Buechner, Editor

PONE-D-25-18559R1

PLOS ONE

Dear Dr. Baumann,

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team.

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Academic Editor

PLOS ONE

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