Compression Headphone Study

A study testing Recording with hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The stimuli consist of speech in quiet, speech in noise, reverberant speech, and music recorded with different hearing aid settings, post-processed for headphone presentation and incorporated in an online sound survey. Participants will receive tablets and headphones to conduct a sound quality rating at home. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hearing Loss
What is being tested?: Recording with hearing aid
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteCanada
Study dates: 10 May 2021to 2 Sep 2021
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults (18-99 years) with ≥3 months hearing aid experience
binaural, symmetric, sensorineural N3 to N4 hearing loss
able to use Android interface and receive a video call on phone/computer
fluent in English

Who cannot join

children/teenagers
normal hearing or hearing loss exceeding N4 by 10dB
cannot wear over-ear headphones

Trial locations and contacts

1 site in 1 country.

Canada1 site

Sonova Innovation Centre Toronto
Mississauga, Ontario, L5L1J3

Other trials in Canada

About this study

Official title: Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss

Conditions: Hearing Loss
Being tested: Recording with hearing aid
Medical subject headings: Hearing Loss

What participants receive

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

Recording with hearing aidDevice
Each participant will listen to sound samples via headphones. Sound samples have been recorded with a hearing aid that was set to each participant's individual hearing loss and different amplification strategies, and an unaided reference. Participants will be asked to rate different aspects of sound quality while listening to the different sound samples.

Study groups in NCT04882709
Study group	Role	What they receive
Hearing aid 1 default amplification strategy	Experimental	Hearing aid 1 default amplification strategy: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with the default settings as specified in the study sponsor's fitting software. Receives: Device: Recording with hearing aid
Hearing aid 2	Experimental	Hearing aid 2: A receiver-in-canal (RIC) hearing aid developed by the another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software. Receives: Device: Recording with hearing aid
Hearing aid 1 strategy 1	Experimental	Hearing aid 1 strategy 1: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality. Receives: Device: Recording with hearing aid
Hearing aid 1 strategy 2	Experimental	Hearing aid 1 strategy 2: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality. Receives: Device: Recording with hearing aid
unaided	No intervention	Unaided recording to be used for normalization of rating results.

What is being measured

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

Sound Quality Rating
Participants moved through a self-guided, double-blinded sound survey which presented sound samples of all hearing aid conditions (see Arms/Groups for conditions) and asked participants to rate the sound quality dimensions on a scale. The rating dimensions and scales were based on a sound quality rating guidance document by Delta Labs (Danmark) ranging from 0 to 100 with step sizes of 1 and descriptive markers at 0 (worst), 20, 40, 60, 80 and 100 (best) depending on the dimension (Reverberation (only assessed for Speech in Quiet and Reverberant Speech), Sound Source Localization, Sound Source Separation, and Timbral Balance). Overall Preference was implemented as a ranking according to the 5-point Mean Opinion Score (bad (1), poor (2), fair (3), good (4), excellent (5); MOS, International Telecommunication Union, 1996).
Measured: 1 hour

Timeline

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

10 May 20212 Sep 2021

First posted12 May 2021
Study start10 May 2021
Primary completion2 Sep 2021
Study completion2 Sep 2021

Why it stopped: No reliable differences across conditions, unacceptable test-retest reliability

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.
Other trials for Hearing LossStudies 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: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04882709
Sponsor's protocol ID: 365
Status last verified: Apr 2024
First submitted: 4 May 2021
Last updated: 13 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss
ClinicalTrials.gov ID: NCT04882709
Acronym / sponsor ID: 365
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: TerminatedReason stopped: No reliable differences across conditions, unacceptable test-retest reliability
Enrolment: 12 participants (actual)
Lead sponsor: Sonova AGIndustry (pharma, biotech, devices)
Collaborators: Sonova Canada Inc.
Study start: 10 May 2021 (actual)
Primary completion: 2 Sep 2021 (actual)
Study completion: 2 Sep 2021 (actual)
First posted: 12 May 2021 (actual)
Results: Posted 13 Aug 2025

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Hearing aid 1 default amplification strategy	Experimental	Device: Recording with hearing aidHearing aid 1 default amplification strategy: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with the default settings as specified in the study sponsor's fitting software.
Hearing aid 2	Experimental	Device: Recording with hearing aidHearing aid 2: A receiver-in-canal (RIC) hearing aid developed by the another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software.
Hearing aid 1 strategy 1	Experimental	Device: Recording with hearing aidHearing aid 1 strategy 1: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality.
Hearing aid 1 strategy 2	Experimental	Device: Recording with hearing aidHearing aid 1 strategy 2: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality.
unaided	No intervention	–Unaided recording to be used for normalization of rating results.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults (18-99 years) with ≥3 months hearing aid experience
binaural, symmetric, sensorineural N3 to N4 hearing loss
able to use Android interface and receive a video call on phone/computer
fluent in English

Key exclusion criteria (3 listed)

children/teenagers
normal hearing or hearing loss exceeding N4 by 10dB
cannot wear over-ear headphones

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
Recording with hearing aidEach participant will listen to sound samples via headphones. Sound samples have been recorded with a hearing aid that was set to each participant's individual hearing loss and different amplification strategies, and an unaided reference. Participants will be asked to rate different aspects of sound quality while listening to the different sound samples.	Device	Hearing aid 1 default amplification strategy, Hearing aid 1 strategy 1, Hearing aid 1 strategy 2, Hearing aid 2

Primary outcome

Sound Quality Rating
Time frame: 1 hour
Participants moved through a self-guided, double-blinded sound survey which presented sound samples of all hearing aid conditions (see Arms/Groups for conditions) and asked participants to rate the sound quality dimensions on a scale. The rating dimensions and scales were based on a sound quality rating guidance document by Delta Labs (Danmark) ranging from 0 to 100 with step sizes of 1 and descriptive markers at 0 (worst), 20, 40, 60, 80 and 100 (best) depending on the dimension (Reverberation (only assessed for Speech in Quiet and Reverberant Speech), Sound Source Localization, Sound Source Separation, and Timbral Balance). Overall Preference was implemented as a ranking according to the 5-point Mean Opinion Score (bad (1), poor (2), fair (3), good (4), excellent (5); MOS, International Telecommunication Union, 1996).

Results and safety

Results posted to the registry on 13 Aug 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
Sound Survey	12	12

Primary outcome: Sound Quality Rating

Time frame: 1 hour. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Hearing Aid 1 Default Amplification Strategy n = 11	Hearing Aid 2 n = 11	Hearing Aid 1 Strategy 1 n = 11	Hearing Aid 1 Strategy 2 n = 11	Unaided n = 11
Reverberation in speech in quiet	69 (55 to 75)	55 (28.75 to 70.75)	71 (64.75 to 87.75)	80 (47.5 to 90)	42 (26 to 59)
Reverberation in reverberant speech	56.5 (50.25 to 72)	54.5 (41 to 70.5)	70 (60.75 to 80.75)	70.5 (51.25 to 73.75)	40.5 (21 to 55.25)
Sound source location in speech in quiet	59 (54.25 to 70.75)	50.5 (39.5 to 67)	61.5 (52.75 to 78)	55 (51.25 to 61.5)	25 (16 to 37.5)
Sound source location in speech in noise	74 (63 to 80.25)	63 (44.75 to 73)	65 (50 to 78.5)	61 (57.75 to 76.75)	43.5 (25.5 to 62.75)
Sound source localization in reverberant speech	45.5 (36.25 to 60.5)	56 (41.5 to 63)	69.5 (51 to 73)	55.5 (50.75 to 67.25)	49 (30.75 to 59.5)
Sound source localization in music	60.5 (53 to 66.25)	69.5 (60.25 to 74)	66.5 (63 to 71)	67.5 (59.75 to 78.75)	44 (24.25 to 56.25)
Sound source separation in speech in quiet	62.5 (53.25 to 74)	59 (56.75 to 71.25)	59.5 (55.75 to 74)	69 (52 to 76.75)	29 (16.5 to 41.25)
Sound source separation in speech in noise	55 (46.75 to 57.25)	52 (40 to 60.25)	70 (53.5 to 75.25)	64.5 (50.75 to 69)	30 (16 to 40)

Population analysed: The median and IQR is presented for each sound quality dimension (Reverberation, Sound Source Separation, Sound Source Location and Overall) in sound scene (speech in quiet, speech in noise, speech in reverberance, music).

Adverse events

Time frame: Data were collected as long as a participant was enrolled in the study, which was from the first to the second appointment. This time frame was about 2 weeks for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Complete Sample	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 Canada Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing Recording with hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in Canada.

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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 13 Aug 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 13 Aug 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?

Sound Quality Rating (time frame: 1 hour). 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 NCT04882709.

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 13 Aug 2025.