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Article
Peer-Review Record

Optimizing Tinnitus Management: The Important Role of Hearing Aids with Sound Generators

Audiol. Res. 2024, 14(4), 674-683; https://doi.org/10.3390/audiolres14040057
by Yuki Kosugi 1,†, Toru Miwa 1,2,*,†, Yuka Haruta 1, Kosuke Hashimoto 1 and Shoko Kato 1
Reviewer 1:
Reviewer 2:
Audiol. Res. 2024, 14(4), 674-683; https://doi.org/10.3390/audiolres14040057
Submission received: 28 May 2024 / Revised: 26 July 2024 / Accepted: 5 August 2024 / Published: 6 August 2024
(This article belongs to the Special Issue Rehabilitation of Hearing Impairment: 2nd Edition)

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Review: Optimizing tinnitus management: the important role of hearing 2 aids with sound generators

The authors aimed to investigate the efficacy and long-term outcomes of tinnitus retraining therapy using hearing aids with or without sound generators as well as only sound generators to provide improved treatment for patients with chronic tinnitus in a retrospective study. They found that hearing aids with and without sound generators were able to manage chronic tinnitus measured with different questionnaires. On the other hand, long-term use of classic hearing aids seemed to worsen the tinnitus burden, which was not found in hearing aids with sound generators.

 

General comments:

The manuscript is well written, the English is very comprehensible. Nevertheless, the statistics of the results have to be clarified, as I found several unclear approaches. In the introduction as well as in the discussion I feel there is a lack of comparisons of different models that could lead to tinnitus. Especially the discussion could profit from such comparisons in view of the data.

 

Specific comments

Abstract:

Please clarify the timeframe of when HAs helped and when not.

Mention the different groups investigated.

Introduction:

L46ff: You refer only to the classic Jastreboff model from 1990. In the last 35 years, several other modern models have been developed, that should be at least briefly mentioned. Maybe not only look on the treatment models but also to the modern models of tinnitus development, especially, as you refer to the hearing loss as one of the main reasons for tinnitus.

L64 ff: The SG HAs are primarily for masking the tinnitus and not for “treatment”, maybe rephrase?

Methods:

L112f: Were the SG only group only fitted with SG HAs without the hearing aid function? Else, the SG would dampen the normal hearing, please clarify. Are these the patients in the control group? This is unclear to me.

Refer to Table 1 for the group sizes of the different subgroups wit HA / SG HA

L128: do you mean “at least” instead of “less”?

Results:

In the iTCI group you have less than 10 patients with a gender ratio of 1:8, how did you perform the tests, especially as an ANOVA requires at least n=10? This is also true for the other parametric tests. I suggest to include these patients in another comparable group or remove them from the analysis.

In your analyses, you show the data of the control and HA group, then you show the SG HA subgroup and the HA subgroups again. Please separate the analyses for the CNT, HA and SG HA groups and the subgroups of both main groups. Maybe also use visual cues to show which subgroup belongs to which main group. This information should then be also included in the Figures,

Add the variance to Figure 1. Additionally it would help to see directly, which values (if there are) are significantly different from each other by using asterisks. Generally, it would be helpful to name the panels A, B…

I do not see, where exactly Suppl. Fig. 1 adds additional information, please mention in the text.

Supplementary Figure 1: As for Figure 1, please add the variance to the histogram data. Additionally it would help to see directly, which values are significantly different from each other by using asterisks.

Discussion:

I still do not understand where the CNT and SG only patients differ, please clarify. Also include the information of all HA vs all SG HA to the discussion.

L217f: here you discuss one possibility of tinnitus reduction, please also mention alternative models, like the Stochastic Resonance of Krauss et al, 2016 or the different central gain approaches.

L227: You discuss the effect of music on tinnitus, is it possible to check, if those patients were especially music-affine, like they play instruments themselves?

Author Response

Specific comments

Abstract:

Please clarify the timeframe of when HAs helped and when not.

>Thank you for your pertinent comment. Based on our results, the first year of HA use was useful for tinnitus symptoms. This has been added included in the Abstract.

Page 1 lines 22-23:

Our findings indicate that HAs are useful in the first year but their prolonged use may exacerbate tinnitus symptoms, whereas HA SGs are effective in the long-term.

Mention the different groups investigated.

> Thank you for your pertinent. I included the different groups investigate in the Abstract.

Page 1 lines 12–14:

Therefore, we investigated the efficacy and long-term outcomes of tinnitus therapy using various HA SG models.

 

Introduction:

L46ff: You refer only to the classic Jastreboff model from 1990. In the last 35 years, several other modern models have been developed, that should be at least briefly mentioned. Maybe not only look on the treatment models but also to the modern models of tinnitus development, especially, as you refer to the hearing loss as one of the main reasons for tinnitus.

>Thank you for your pertinent comment. As per your suggestion, I have included information about several other models in Introduction section.

Page 2 lines 53-63:

In the last 35 years, various conceptional models of tinnitus have been proposed. Zenner and Zalaman's Cognitive Desensitized Therapy reduces tinnitus burden and improves patients’ quality of life [12]. Zenner et al. argue that tinnitus sensitization arises from interpreting sound as unpredictable and fear-inducing, leading to helplessness [13]. Conversely, McKenna et al.'s Cognitive-Behavioral model links distress to negative thoughts about tinnitus, provoking emotional distress and maladaptive behaviors [14]. Whereas Ghodratitoostani's Neurofunctional Tinnitus Model (NfTM) emphasizes the role of cognitive-emotional appraisal processes (CAAP) in tinnitus distress, proposing stages of neutral and clinical distress [15]. Furthermore, a new Conceptual Cognitive Framework (CCF) incorporates these cognitive processes to model and test causality in tinnitus distress and management [16].

L64 ff: The SG HAs are primarily for masking the tinnitus and not for “treatment”, maybe rephrase?

> Thank you for your pertinent comment. I have omitted the word, “treatment”.

Page 2 lines 75–76:

SG HAs comprise a masker or SG, serving as a partial masker for adaptation to tinnitus, in addition to the HA [18].

 

Methods:

L112f: Were the SG only group only fitted with SG HAs without the hearing aid function? Else, the SG would dampen the normal hearing, please clarify. Are these the patients in the control group? This is unclear to me.

> Thank you for your pertinent comment. Patients with non-hearing loss tinnitus only wore SGs without hearing aid function as it does not affect hearing.

Refer to Table 1 for the group sizes of the different subgroups wit HA / SG HA

>Thank you for your pertinent comment. I have included a reference to Table 1 in the Methods section as per your suggestion.

Page 3 lines 132–133:

Additionally, the control group (CNT) included patients who did not use HAs, SG HAs or SGs (Table 1).

L128: do you mean “at least” instead of “less”?

> Thank you for your pertinent comment. I have revised “less” to “at least” as appropriate.

Page 3 line 142:

score or at least by 16 points at the end of the assessment

Results:

In the iTCI group you have less than 10 patients with a gender ratio of 1:8, how did you perform the tests, especially as an ANOVA requires at least n=10? This is also true for the other parametric tests. I suggest to include these patients in another comparable group or remove them from the analysis.

> Thank you for your pertinent comment. As per your suggestion, I have removed the iTCI group from the analysis.

In your analyses, you show the data of the control and HA group, then you show the SG HA subgroup and the HA subgroups again. Please separate the analyses for the CNT, HA and SG HA groups and the subgroups of both main groups. Maybe also use visual cues to show which subgroup belongs to which main group. This information should then be also included in the Figures,

> Thank you for your pertinent comment. I revised the results as per your suggestion.

Page 4 and 5 lines 162–178:

3.2.1 Group-wise comparisons among the CNT, HA, SG HAs, and SG groups

At 1 year, the HA, SG HA, and SG groups demonstrated greater rates of improvement in THI scores than the CNT group [HAs 53.6% (n = 28), SG HAs 43.9% (n = 271), and SG 41.9% (n = 74) vs CNT 20.8% (n = 53), Figure S1]. Similarly, after 2 years of follow-up, the SG HA and SG groups demonstrated greater rates of improvement in THI scores than the CNT group [SG HAs 50.9% (n = 271), and SG 37.8% (n = 74), Figure S1]. However, the HA group demonstrated lower rates of improvement than the CNT group (HA 10.7% (n = 28) vs CNT 17.0% (n = 53) , Figure S1).

3.2.2 Group-wise comparisons among the CNT, HA, various models of SG HAs (ZEN and TTHA/TTC) and SG (TT/TTSG and TCI ) groups

The tinnitus improvement rates are shown in Figure 1. Group-wise comparisons of THI improvement rate revealed that at 1 year, the ZEN group (50.0%; SG HAs) demonstrated greater improvement rates than TCI (46.5%), TT/TTSG (35.5%; SG) and TTHA/TTC (18.8%; SG HAs) groups (Figure 1). Similarly, after 2 years of follow-up, the ZEN (55.1%; SG HAs) demonstrated better rates of improvement than TTHA/TTC (37.5%; SG HAs), TCI (46.5%), and TT/TTSG (25.8%; SG) groups (Figure 1). The mean ± standard deviation of THI scores is shown in Table 2.

Add the variance to Figure 1. Additionally it would help to see directly, which values (if there are) are significantly different from each other by using asterisks. Generally, it would be helpful to name the panels A, B…

> Thank you for your pertinent comment. Figure 1 compares percentages and does not include statistical analysis. Therefore, we did not examine whether the numbers were significantly larger, and we did not indicate asterisks. A and B have been added to the panels for better clarity.

I do not see, where exactly Suppl. Fig. 1 adds additional information, please mention in the text.

> Thank you for your pertinent comment. I have included in-text citations for Fig S1 as required.

Supplementary Figure 1: As for Figure 1, please add the variance to the histogram data. Additionally it would help to see directly, which values are significantly different from each other by using asterisks.

> Thank you for your pertinent comment. As explained previously, Supplementary Figure S1 compares percentages and does not include statistical studies. Therefore, we have not included asterisks.

Discussion:

I still do not understand where the CNT and SG only patients differ, please clarify. Also include the information of all HA vs all SG HA to the discussion.

> Thank you for your pertinent comment. CNT is the group without any device, whereas the SG group uses the Sound generator without the hearing aid function. Details regarding comparisons between HAs and SG HAs have been included in the second paragraph of Discussion section.

L217f: here you discuss one possibility of tinnitus reduction, please also mention alternative models, like the Stochastic Resonance of Krauss et al, 2016 or the different central gain approaches.

>Thank you for your pertinent comment. I have included other models for tinnitus reduction in the Discussion section as per your suggestion.

Page 9 lines 233–239:

In addition to this model, alternative explanations for tinnitus include the Stochastic Resonance model by Krauss et al., 2016, which emphasizes the role of SR in enhancing weak auditory signals [26]. Furthermore, various central gain approaches suggest that increased central neuronal gain compensates for reduced auditory input, leading to hyperactivity and tinnitus [27]. Collectively, these alternative models offer valuable perspectives on the mechanisms underlying tinnitus and potential avenues for tinnitus reduction.

 

L227: You discuss the effect of music on tinnitus, is it possible to check, if those patients were especially music-affine, like they play instruments themselves?

> Thank you for your pertinent suggestions. Although it would be interesting to see if the patients with tinnitus play instruments, we are unable to confirm this because this study is retrospective study.

Reviewer 2 Report

Comments and Suggestions for Authors

line 14: TRT means more than the use of questionnaires and sound generators, so do not claim that this study emphasizes TRT as a whole

line 37: "to the condition", which condition, add a few words to explain

line 53: .... memories: please add a word such as "feelings" or "thoughts" (non-existing memories)

line 73: definition of pink noise, see cf. https://en.wikipedia.org/wiki/Pink_noise, not really equivalent to "intermediate between white noise and speeche noise)

line 93: written informed consent was not required: why not, because it is required in a lot of countries, like USA, Europe, etc.

line 123: control group, please adjust more details about the control group, like number (53), way of involvement, range of tinnitus complaints <-- which questions, etc.

line 147: please add the meaning of some other abbreviations, like the different HA/SG brands/types (for clarification), e.g. difference between iTCI & TCI is not clear

line 151: Is it right that the rate of improvement is based on THI scores? It is not totally clear, please add!

line 160: My observation is that there is no improvement at all in the control group, baes upon the THI scores, but this is not the case in figure 1, how to explain?

line 161: idem (line 147)

line 202: in all figures 1-4 I am surprised that impovement rarios > 0  are plotted, so no negative improvement reatios (or deterioration), what is the reason?

line 222: "worsen" this brings me to the opinion that it should be good to add a figure to show the amelioration or deterioration difference between year 1 and year 2

line 271: due to the large s.d.'s I would suggest that you will discuss some typical remarks of subjects regarding amelioration or deterioration differences, please add

line 272: in this study the outcome is defined by using questionnaires and not by measuring tools like tinnitus matching or real estimation methods, please discuss!

 

Comments on the Quality of English Language

No further comments.

Author Response

Responses to Comments and Suggestions

line 14: TRT means more than the use of questionnaires and sound generators, so do not claim that this study emphasizes TRT as a whole

> Thank you for your pertinent comment. I rephrased “TRT” to “tinnitus therapy”.

 

line 37: "to the condition", which condition, add a few words to explain

>Thank you for your pertinent suggestion. I have revised the text to better explain the condition.

Page 1 line 35:

foster adaptation to the condition of tinnitus.

 

line 53: .... memories: please add a word such as "feelings" or "thoughts" (non-existing memories)

> Thank you for your pertinent suggestion. I have revised the text accordingly.

Page 2 line 51–53:

association with negative memories such as "feelings" or "thoughts" (non-existing memories) [11].

 

line 73: definition of pink noise, see cf. https://en.wikipedia.org/wiki/Pink_noise, not really equivalent to "intermediate between white noise and speech noise)

> Thank you for your pertinent suggestion. I deleted this sentence to avoid any confusion.

 

line 93: written informed consent was not required: why not, because it is required in a lot of countries, like USA, Europe, etc.

> Thank you for your pertinent comment. I apologize for the confusion as this description was incorrect. I revised it accordingly.

Page 3 line 103:

Written informed consent was obtained for this study.

 

line 123: control group, please adjust more details about the control group, like number (53), way of involvement, range of tinnitus complaints <-- which questions, etc.

> Thank you for your pertinent comment. These details were listed in Results section. As per your comments, I have added more detailed methods for the control group.

 

line 147: please add the meaning of some other abbreviations, like the different HA/SG brands/types (for clarification), e.g. difference between iTCI & TCI is not clear

> Thank you for your pertinent comment. Per your suggestions, I have defined the abbreviations and included the various HA/SG brands/types/characteristics.

 

line 151: Is it right that the rate of improvement is based on THI scores? It is not totally clear, please add!

> Thank you for your pertinent comment. The rate of improvement is based on THI scores. I have revised it as the THI improvement rate.

 

line 160: My observation is that there is no improvement at all in the control group, baes upon the THI scores, but this is not the case in figure 1, how to explain?

> Thank you for your pertinent comment. The mean of THI scores and rate of tinnitus improvement were different, indicating the differences between Table 1 and Figure 1.

 

line 161: idem (line 147)

> Thank you for your pertinent comment. This has been revised accordingly.

 

line 202: in all figures 1-4 I am surprised that impovement rarios > 0  are plotted, so no negative improvement reatios (or deterioration), what is the reason?

> Thank you for your pertinent comment. According to the pre-treatment and post-treatment comparisons by division in Figure 2,3, more than 1 is worse and less than 1 is better for VAS and STAI; whereas, the opposite is true for EQS in Figure 4: more than 1 is better and less than 1 is worse. Therefore, there were no negative improvement ratio. As for Figure 1, you are correct because there was an improvement.

 

line 222: "worsen" this brings me to the opinion that it should be good to add a figure to show the amelioration or deterioration difference between year 1 and year 2

> Thank you for your pertinent comment. However, the figure was structured like a spaghetti plot, which was difficult to read due to the several groups being compared.

 

line 271: due to the large s.d.'s I would suggest that you will discuss some typical remarks of subjects regarding amelioration or deterioration differences, please add

> Thank you for your pertinent comment. As per your suggestion, although we would like to include remarks regarding the subject, we were unable to as this is a retrospective study.

 

line 272: in this study the outcome is defined by using questionnaires and not by measuring tools like tinnitus matching or real estimation methods, please discuss!

> Thank you for your pertinent comment. I have added this aspect as a limitation of the study.

Page 10 lines 289–292:

Second, although this study demonstrated differences among the models, the mechanism is only speculative and requires further verification using imaging tests, such as fMRI and MEG or other measuring tools like tinnitus matching or real estimation methods.

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