Hearing Aid Amplification Schemes Adjusted to Tinnitus Pitch: A Randomized Controlled Trial

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

 

The manuscript is very interesting and well written. The topic is relevant and up to date.  The introduction provides sufficient background of the study questions and include all relevant references. The research design is appropriated and well planned using  randomized trials but the amount of test participants and the study design (cross over design) might contribute to the lack of significance difference between the treatment groups. It is not written if the authors calculated the adequate effect size of the study.  It would be important to add this in the section 2. The methods are adequately described. The results are also clearly presented and well discussed. The figures are clear and well-presented.

Even though the manuscript has a high quality, there are some things that could be improved: 1)      it seems that there are many places in the text where it seems a double space between words. Please check it. 2)      In Figure 1 might be important to show the NAL_NL2 REIG target for the participant as well in order to see how good the measured REIG in relation to the target is. 3)       Was calculated the effect size for the sample study with crossover design? The lack of difference between treatment groups could be related to the sample size is too small. 4)      Regarding the inclusion criteria for the participants, the choice of selecting participants with previous amplification also have contributed to the lack of the of statistically significant difference between treatments because perhaps the big change in the TFI has already occurred before the inclusion in the study (in the first six months that the participants got the hearing aids.  5)      Page 14 line 423 the authors must correct the sentence since it is contradictory “Despite the TFI score after notched-amplification was significantly better than that after Boost amplification, this difference did not reach the required clinical significance for the TFI”.

Author Response

Thanks for the comments on our manuscript and for taking the time to read it.

Comments 1: it seems that there are many places in the text where it seems a double space between words. Please check it.

Response 1: Thanks for spotting this, the double spaces have been removed in the second version.

Comments 2: In Figure 1 might be important to show the NAL_NL2 REIG target for the participant as well in order to see how good the measured REIG in relation to the target is.

Response 2: This is good observation and we agree that this additional information would help to place the measurements in context. Unfortunately, we have gone through the exported files from the Interacoustics measurements and the data points of the REIG targets are not stored. We have no longer access to this device so we don't see a way of obtaining these curves for its representation in the manuscript.

Comments 3:  Was calculated the effect size for the sample study with crossover design? The lack of difference between treatment groups could be related to the sample size is too small.

Response 3: Yes, the effect size was calculated for this particular crossover design. Lines 210-212 explain the details of this effect size. We believe that finding no differences between treatments can be attributed to several contributing factors.

Comments 4: Regarding the inclusion criteria for the participants, the choice of selecting participants with previous amplification also have contributed to the lack of the of statistically significant difference between treatments because perhaps the big change in the TFI has already occurred before the inclusion in the study (in the first six months that the participants got the hearing aids. 

Response 4: Thanks for this observation. We believe that this is very likely the case in here. As we indicated in our introduction (lines 96-98), our goal was to specifically test the additional effect of a modified amplification strategy over standard amplification, since a standard amplification has been shown to be effective in tinnitus management. We think that this is particularly important in order to assess the efficacy of new or existing strategies that might claim to be more effective than the regular prescription.

Comments 5: Page 14 line 423 the authors must correct the sentence since it is contradictory “Despite the TFI score after notched-amplification was significantly better than that after Boost amplification, this difference did not reach the required clinical significance for the TFI”.

Response 5: Thanks for spotting this. We have changed the sentence to the following: "Despite the TFI score after notched-amplification was lower than after Boost amplification, this difference did not reach the required clinical significance for the TFI." 

Reviewer 2 Report

Comments and Suggestions for Authors

The manuscript content is novel, and a valuable contribution to the literature. It is well written with rigor methodology. The finding is still important, as it steers clinical practice towards patient-orientated care and selection of hearing aids. The study after some suggested improvementswould be suitable for publication (Minor Revision recommended).

Title, Abstract, Keywords: clear and concise.

Introduction: it is well-structured.

Line 70: Continue and add the following phrase with the citation: DOI: 10.3389/fneur.2025.1672762

-“Furthermore, recent evidence indicates that the intensity of the tinnitus percept itself can negatively impact speech comprehension, a key aspect of hearing aid benefit.”

Materials and Methods: the criteria is well defined, there is an excellent detail on hearing aids and their fitting software, and the sample size calculation is provided and justified.

Tinnitus pitch Question: where patient then excluded with  a tinnitus pitch >8 kHz? In the clinical practice, nowdays, we see patients with pitch 12kHz. Might be beneficial of mentioning it in the limitation section.  

Results: the clinical vs statistical significance of the findings are clearily stated.

Figure 4-7 has little discussion on the text, some further assesment in the text might provide more clarity and accuracy for these figures.

Discussion: accurately summerizes the main findings.

Line 480: “…well-known correlated factors of tinnitus [43]." Here, after this has been mentioned, add the following discusiion and DOI: 10.3390/audiolres15030072. Hence, a discussion about the systemic, non-auditory factors is mentioned that vary among tinnitus patients and could influence their experience and preferences. Which this reinforces the concept that a patient's unique tinnitus profile, influenced by both central and systemic factors, ultimately drives their preference for a particular hearing aid setting.

Conclusion: well stated, with key take message and the necessary call for further research.  

Author Response

Thanks for taking the time to go through our paper, we believe that your comments have helped to improve it.

Comments 1: Line 70: Continue and add the following phrase with the citation: DOI: 10.3389/fneur.2025.1672762

-“Furthermore, recent evidence indicates that the intensity of the tinnitus percept itself can negatively impact speech comprehension, a key aspect of hearing aid benefit.”

Response 1: Thanks for this source, we have added the following in lines 70-72: "Furthermore, recent evidence indicates that the intensity of the tinnitus percept itself can negatively impact speech comprehension, a key aspect of hearing aid benefit [14]. "

Comments 2: Tinnitus pitch Question: where patient then excluded with  a tinnitus pitch >8 kHz? In the clinical practice, nowdays, we see patients with pitch 12kHz. Might be beneficial of mentioning it in the limitation section.  

Response 2: Thanks for this observation. Yes, they were excluded. We stated this in lines 177-179: "Due to the limitation of 8 kHz as the maximum frequency at which the notch can be set in the study devices, participants with a higher tinnitus frequency were excluded." In the new version, we have stated the following in the limitation section as suggested, lines 512-515: "Additionally, it is worth mentioning that the 8kHz limitation of the notch setting might also play a role in the results we observed, as it remains unclear how patients with tinnitus at higher frequencies might respond."

Comments 3: Figure 4-7 has little discussion on the text, some further assesment in the text might provide more clarity and accuracy for these figures.

Response 3: We agree that one of these figures had not enough discussion on the text. We have added the following paragraph to extend the explanation of figure 4. Lines 341-343: "As shown in the figure, TFI score changes varied across participants, with some patients exhibiting differences of nearly 30 points between settings." We did not include further explanation of the figures since any statistical analysis performed resulted in no significant differences. 

Comment 4: Line 480: “…well-known correlated factors of tinnitus [43]." Here, after this has been mentioned, add the following discusiion and DOI: 10.3390/audiolres15030072. Hence, a discussion about the systemic, non-auditory factors is mentioned that vary among tinnitus patients and could influence their experience and preferences. Which this reinforces the concept that a patient's unique tinnitus profile, influenced by both central and systemic factors, ultimately drives their preference for a particular hearing aid setting.

Response 4: Thanks for this citation. We have added the following in lines 494-498: "Altogether, a discussion of systemic, non-auditory factors is warranted, as these vary among tinnitus patients and may influence their experiences and preferences. This reinforces the concept that each patient’s unique tinnitus profile, shaped by both central and systemic factors [45], ultimately guides their preference for a particular hearing aid setting."

Reviewer 3 Report

Comments and Suggestions for Authors

The study is very interesting and addresses a highly relevant topic. Tinnitus is undoubtedly a very common condition, and the investigation of different management options is of fundamental importance. The authors have undoubtedly carried out excellent work. The manuscript is clear, well-structured, and comprehensive. However, the generalizability of the results is clearly limited by the small number of patients included. The work is accepted in its present form for publication.

Author Response

Comments 1: The study is very interesting and addresses a highly relevant topic. Tinnitus is undoubtedly a very common condition, and the investigation of different management options is of fundamental importance. The authors have undoubtedly carried out excellent work. The manuscript is clear, well-structured, and comprehensive. However, the generalizability of the results is clearly limited by the small number of patients included. The work is accepted in its present form for publication.

Response 1: Thanks for the comments on our manuscript. Indeed, the small number of patients is one of the limitations of this study, which we tried to overcome by the chosen crossover design.