- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882709
Compression Headphone Study
August 11, 2025 updated by: Sonova AG
Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss
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.
The survey will involve a training session and within-subject repeated measures.
Stimuli presentation will be randomized by sound quality rating tool.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Mississauga, Ontario, Canada, L5L1J3
- Sonova Innovation Centre Toronto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- children/teenagers
- normal hearing or hearing loss exceeding N4 by 10dB
- cannot wear over-ear headphones
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hearing aid 1 default amplification strategy
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.
|
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.
|
|
Experimental: Hearing aid 2
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.
|
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.
|
|
Experimental: Hearing aid 1 strategy 1
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.
|
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.
|
|
Experimental: Hearing aid 1 strategy 2
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.
|
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.
|
|
No Intervention: unaided
Unaided recording to be used for normalization of rating results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jinyu Qian, PhD, Sonova Canada Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2021
Primary Completion (Actual)
September 2, 2021
Study Completion (Actual)
September 2, 2021
Study Registration Dates
First Submitted
May 4, 2021
First Submitted That Met QC Criteria
May 11, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
August 13, 2025
Last Update Submitted That Met QC Criteria
August 11, 2025
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 365
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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