Hearing Loss, SensorineuralNCT05521308

Investigating Hearing Aid Frequency Response Curves

A study testing Hearing Aid - Standard Curve, Hearing Aid - Variation #1 and Hearing Aid - Variation #2 in people with Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Sonova AG at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid… Read more about this study

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Hearing Loss, Sensorineural, Hearing Loss, Bilateral
What is being tested?: Hearing Aid - Standard Curve, Hearing Aid - Variation #1 and Hearing Aid - Variation #2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteCanada
Study dates: 24 Oct 2022to 11 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

N2 - N4 Hearing losses
Health Outer ear
no visible congenital or traumatic deformity of the outer ear
Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.
Ability to answer questions and repeat sentences
No history of problematic tinnitus or pain/discomfort from loud sounds

Show all 11Show fewer

No history of active drainage from the ears in the past 90 daysInformed consent as documented by signature
Willingness to wear different styles of couplings
Willingness to wear binaural fitting
Experienced Users = more than 3 months of hearing aid experience. If not more than 3 months, they will be considered a new user (Experience will not exclude them from study, only will be used to categorize them)
Ability to travel throughout facility

Who cannot join

Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)
Limited mobility/not able to come to the scheduled visit
Inability to produce reliable hearing test results
History of active drainage from the ear in the previous 90 days
Abnormal appearance of the eardrum and ear canal.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Sonova - Kitchener
Kitchener, Ontario, N2E 1Y6

Other trials in Canada

About this study

Read the detailed description

Internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. This should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality. However, the investigators are currently unsure if implementing these new frequency response curves will be preferred by the manufacturer's clients. Therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music.

Conditions: Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Being tested: Hearing Aid - Standard Curve, Hearing Aid - Variation #1, Hearing Aid - Variation #2, Hearing Aid - Variation #3, Hearing Aid - Variation #4
Keywords: Hearing Loss, Hearing Aids, Frequency Response Curves
Medical subject headings: Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hearing Aid - Standard CurveDevice
Our current hearing aids which will be programmed to our standard frequency response curve.
Hearing Aid - Variation #1Device
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #2Device
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #3Device
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #4Device
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.

Study groups in NCT05521308
Study group	Role	What they receive
Participants with Hearing Loss	Experimental	Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions. Receives: Device: Hearing Aid - Standard Curve; Device: Hearing Aid - Variation #1; Device: Hearing Aid - Variation #2; Device: Hearing Aid - Variation #3; Device: Hearing Aid - Variation #4

What is being measured

The primary outcome is the main question the study is designed to answer.

Streaming Sound Quality Ratings
Pre-filtered sound samples (based on frequency response curves) will be presented via a paired comparison task in which participants will determine which sound sample they prefer (i.e. better sound quality). Sound samples will be presented via hearing aids that are programmed to the participant's hearing loss.
Participant's will be presented with two samples at a time and will choose which sample they prefer. For example, if Sample A was preferred over Sample B, then Sample A gets a score of 1. If Sample B was preferred over Sample A, then Sample B gets a score of 1. At the end of the task, scores will be tallied to determine which sample was preferred the most overall. There will be 5 different samples. The minimum value for the tallied score would be 0 (the sample was not preferred at all) and the maximum value would be 8 (implying that the sample was preferred in all trials). Higher scores mean that the sample was preferred more and lowers scores mean the sample was not preferred.
Measured: 60 minutes

Secondary outcomes (3)

Sound Quality Rating - Live - Counts
Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and will be asked to make ratings in the lab and outdoors.
Similar to Outcome 1, scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Measured: 60 minutes
Sound Quality Rating - Live - Preferences
Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and determine which program they prefer to listen to.
Similar to Outcome 1, scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Highers scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Measured: 60 minutes
US Matrix Test in Quiet - SRT
Oldenburg Sentence Test (OLSA) sentences were presented to participants while they were aided under the standard curve, aided under curve #4, and unaided. Participants are presented with sentences from a loudspeaker placed infront of them and asked to repeat what they heard. Correct repitition results in the next sentence to be presented at a lower sound level. Incorrect repetition results in an increase in presentation level for the next sentence. 20 sentences are presented for each conidition (i.e., unaided, aided with the standard curve, and aided under curve #4). Speech Recognition Threshold at 50% (SRT50) correctness scores were calculated and compared amongst the three conditions. SRT50 is measured in decibel (dB) which is a unit on scale. The scale has no upper or lower limits, however lower scores indicate better performance.
Measured: 30 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 202211 Jan 2023

First posted30 Aug 2022
Study start24 Oct 2022
Primary completion11 Jan 2023
Study completion11 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: The study is not a crossover study in it's true sense as there is only one arm. All participants will undergo all testing and will test each hearing aid variation. It should be noted that testing a different hearing aid variation (i.e., intervention) is done by simply clicking a button and having the hearing aid switch into a different variation. In this study, participants will go back and forth between different variations in order to make preference selections (Live Sound Quality task or US Matrix Test task). Additionally, in other outcome measures, participants will listen to pre-recorded stimuli that have the various frequency response curves applied. In this case, participants once again will be exposed to different hearing aid curves while simply listening via hearing aids and making preference selections. In the end, participants can be exposed to different hearing aid variations (i.e., interventions) simultaneously and also have the ability to go back and forth.
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05521308
Sponsor's protocol ID: SRF-3167
Status last verified: Nov 2023
First submitted: 26 Aug 2022
Last updated: 24 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Vaisberg J, Folkeard P, Levy S, Dundas D, Agrawal S, Scollie S. Sound Quality Ratings of Amplified Speech and Music Using a Direct Drive Hearing Aid: Effects of Bandwidth. Otol Neurotol. 2021 Feb 1;42(2):227-234. doi: 10.1097/MAO.0000000000002915.
PubMed 32976346
Harianawala J, Galster J, Hornsby B. Psychometric Comparison of the Hearing in Noise Test and the American English Matrix Test. J Am Acad Audiol. 2019 Apr;30(4):315-326. doi: 10.3766/jaaa.17112. Epub 2018 Sep 25.
PubMed 30461418
Wu YH, Stangl E, Chipara O, Hasan SS, Welhaven A, Oleson J. Characteristics of Real-World Signal to Noise Ratios and Speech Listening Situations of Older Adults With Mild to Moderate Hearing Loss. Ear Hear. 2018 Mar/Apr;39(2):293-304. doi: 10.1097/AUD.0000000000000486.
PubMed 29466265
Neuman AC, Bakke MH, Hellman S, Levitt H. Effect of compression ratio in a slow-acting compression hearing aid: paired-comparison judgments of quality. J Acoust Soc Am. 1994 Sep;96(3):1471-8. doi: 10.1121/1.410289.
PubMed 7963011

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hearing Loss, Sensorineural trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigating Hearing Aid Frequency Response Curves
ClinicalTrials.gov ID: NCT05521308
Acronym / sponsor ID: SRF-3167
Conditions: Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Keywords: Hearing Loss, Hearing Aids, Frequency Response Curves
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Sonova AGIndustry (pharma, biotech, devices)
Study start: 24 Oct 2022 (actual)
Primary completion: 11 Jan 2023 (actual)
Study completion: 11 Jan 2023 (actual)
First posted: 30 Aug 2022 (actual)
Results: Posted 24 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The study is not a crossover study in it's true sense as there is only one arm. All participants will undergo all testing and will test each hearing aid variation. It should be noted that testing a different hearing aid variation (i.e., intervention) is done by simply clicking a button and having the hearing aid switch into a different variation. In this study, participants will go back and forth between different variations in order to make preference selections (Live Sound Quality task or US Matrix Test task). Additionally, in other outcome measures, participants will listen to pre-recorded stimuli that have the various frequency response curves applied. In this case, participants once again will be exposed to different hearing aid curves while simply listening via hearing aids and making preference selections. In the end, participants can be exposed to different hearing aid variations (i.e., interventions) simultaneously and also have the ability to go back and forth.

Arm	Type	Receives
Participants with Hearing Loss	Experimental	Device: Hearing Aid - Standard Curve, Device: Hearing Aid - Variation #1, Device: Hearing Aid - Variation #2, Device: Hearing Aid - Variation #3, Device: Hearing Aid - Variation #4Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

N2 - N4 Hearing losses
Health Outer ear
no visible congenital or traumatic deformity of the outer ear
Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.
Ability to answer questions and repeat sentences

Key exclusion criteria (5 listed)

Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)
Limited mobility/not able to come to the scheduled visit
Inability to produce reliable hearing test results
History of active drainage from the ear in the previous 90 days
Abnormal appearance of the eardrum and ear canal.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hearing Aid - Standard CurveOur current hearing aids which will be programmed to our standard frequency response curve.	Device	Participants with Hearing Loss
Hearing Aid - Variation #1Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.	Device	Participants with Hearing Loss
Hearing Aid - Variation #2Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.	Device	Participants with Hearing Loss
Hearing Aid - Variation #3Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.	Device	Participants with Hearing Loss
Hearing Aid - Variation #4Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.	Device	Participants with Hearing Loss

Primary outcome

Streaming Sound Quality Ratings
Time frame: 60 minutes
Pre-filtered sound samples (based on frequency response curves) will be presented via a paired comparison task in which participants will determine which sound sample they prefer (i.e. better sound quality). Sound samples will be presented via hearing aids that are programmed to the participant's hearing loss. Participant's will be presented with two samples at a time and will choose which sample they prefer. For example, if Sample A was preferred over Sample B, then Sample A gets a score of 1. If Sample B was preferred over Sample A, then Sample B gets a score of 1. At the end of the task, scores will be tallied to determine which sample was preferred the most overall. There will be 5 different samples. The minimum value for the tallied score would be 0 (the sample was not preferred at all) and the maximum value would be 8 (implying that the sample was preferred in all trials). Higher scores mean that the sample was preferred more and lowers scores mean the sample was not preferred.

3 secondary outcomes

Sound Quality Rating - Live - Counts
Time frame: 60 minutes
Sound Quality Rating - Live - Preferences
Time frame: 60 minutes
US Matrix Test in Quiet - SRT
Time frame: 30 Minutes

Results and safety

Results posted to the registry on 24 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Hearing Loss	33	33

Primary outcome: Streaming Sound Quality Ratings

Time frame: 60 minutes. Mean (Standard Error). Unit: Mean Preference Counts per Participant

Measure	Participants With Hearing Loss n = 22
Numbe of times Variation 1 was preferred over variation 2 across all genres per participant.	10.7 (0.915)
Numbe of times Variation 1 was preferred over variation 3 across all genres per participant.	9.41 (0.805)
Numbe of times Variation 2 was preferred over variation 1 across all genres per participant.	7.46 (0.939)
Number of times variation 2 was rated higher in sound quality than variation 3 across all samples	5.91 (0.588)
Numbe of times Variation 3 was preferred over variation 1 across all genres per participant.	8.32 (0.815)
Numbe of times Variation 3 was preferred over variation 2 across all genres per participant.	8.05 (0.757)
Numbe of times Variation 1 was rated the same as variation 2 across all genres per participant.	3.13 (0.487)
Numbe of times Variation 1 was rated the same as variation 3 across all genres per participant.	3.59 (0.462)

Participants With Hearing Loss: Mean Difference (Final Values): 0.38 (95% CI 0.20 to 1.00), p <0.001, ANOVA
Participants With Hearing Loss: Mean Difference (Final Values): 3.23 (95% CI 0.41 to 6.05), p = 0.02, t-test, 2 sided
Participants With Hearing Loss: Mean Difference (Final Values): 0.35 (95% CI 0.18 to 1.00), p <0.001, ANOVA

Population analysed: Out of 33 participants, 4 were pilot participants so their data was not analyzed for the final statistical analysis and 5 participants data was removed due to HL severity. Additionally, 2 participants data was removed for the final analysis as they struggled to understand the tasks within the study. In the end, 22 participants data was used for the final analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were exposed to multiple interventions at once and had the ability to cycle through the various interventions (frequency curves). For this reason, adverse event data would have been collected per task and not intervention due to the quick exposure to multiple interventions. Adverse Event Data per participant was collected and is reported below. Sound Quality Ratings - Streaming - 60 minutes Sound Quality Ratings - Live - 60 minutes US Matrix Test Task in Quiet - 30 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Hearing Loss	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32976346Vaisberg J, Folkeard P, Levy S, Dundas D, Agrawal S, Scollie S. Sound Quality Ratings of Amplified Speech and Music Using a Direct Drive Hearing Aid: Effects of Bandwidth. Otol Neurotol. 2021 Feb 1;42(2):227-234. doi: 10.1097/MAO.0000000000002915.
Background: PubMed 30461418Harianawala J, Galster J, Hornsby B. Psychometric Comparison of the Hearing in Noise Test and the American English Matrix Test. J Am Acad Audiol. 2019 Apr;30(4):315-326. doi: 10.3766/jaaa.17112. Epub 2018 Sep 25.
Background: PubMed 29466265Wu YH, Stangl E, Chipara O, Hasan SS, Welhaven A, Oleson J. Characteristics of Real-World Signal to Noise Ratios and Speech Listening Situations of Older Adults With Mild to Moderate Hearing Loss. Ear Hear. 2018 Mar/Apr;39(2):293-304. doi: 10.1097/AUD.0000000000000486.
Background: PubMed 7963011Neuman AC, Bakke MH, Hellman S, Levitt H. Effect of compression ratio in a slow-acting compression hearing aid: paired-comparison judgments of quality. J Acoust Soc Am. 1994 Sep;96(3):1471-8. doi: 10.1121/1.410289.
Individual participant dataSharing planned: No

Related trials for Hearing Loss, Sensorineural

Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jinyu Qian, PhD principal investigator

Sonova AG

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Streaming Sound Quality Ratings (time frame: 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05521308, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.