- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07501312
Remote Microphone Performance Comparison in Adults With Hearing Loss
May 27, 2026 updated by: Sonova AG
This study will compare far-field speech understanding in noise using a hearing aid alone, with using a hearing aid plus a Roger remote microphone.
It will also compare the HA+Roger mic to two other manufacturers' hearing aids plus remote mic systems in the same condition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will recruit 15-20 hearing impaired experienced hearing aid adult users.
Participants will be fit with three sets of hearing aids (Phonak devices, plus two competitor devices) and the associated remote microphone from each manufacturer.
Speech perception will be measured using the validated AZ Bio test, and will be given in both the hearing aid alone condition, as well as the hearing aid plus remote microphone condition.
The participant will be seated in the center of a room approximately 7m by 5.25m with a loudspeaker approximately 3 m away, at 0 degree azimuth.
Four loudspeakers will also be placed in the corners of the room.
For the quiet condition, target speech will be presented from the loudspeaker in front of the participant, for the noise condition speech will be presented from the front with speech babble presented from each of the corner loudspeakers.
The speech understanding score in both quiet and in noise will be measured for hearing aids alone, and hearing aids plus the appropriate compatible remote microphone.
Study Type
Interventional
Enrollment (Actual)
19
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
-
-
Illinois
-
Aurora, Illinois, United States, 60504
- Sonova US Corporate Services
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Bilateral sensorineural hearing loss
- Experienced bilateral hearing aid users
- Fluent in English, ability to read and write in English
- Able to produce a reliable study result
- Willing to comply with all study requirements
Exclusion Criteria:
- Limited/inconsistent/no prior use of hearing aids
- Self-reported ear-related pathology(including but not limited to: otorrhea within the past 90 days, dizziness, sudden onset or worsening hearing loss within the past 90 days, otalgia)
- Visible deformity of the ear
- Chronic, severe tinnitus
- Unilateral hearing loss
- Single sided deafness
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phonak device first, then Device A, then Device B
Participants fit and tested with Phonak devices first, then Devices A, then Devices B
|
Phonak hearing aid, either used alone or with the compatible remote microphone
First competitor hearing aid, either used alone or with compatible remote microphone
Second competitor hearing aid, either used alone or with compatible remote microphone
|
|
Experimental: Phonak device first, then Device B, than Device A
Participants fit and tested with Phonak device first, then Device B, then Device A
|
Phonak hearing aid, either used alone or with the compatible remote microphone
First competitor hearing aid, either used alone or with compatible remote microphone
Second competitor hearing aid, either used alone or with compatible remote microphone
|
|
Experimental: Device A first, than Phonak devices, then Device B
Participants fit and tested with Device A first, than Phonak device, then Device B
|
Phonak hearing aid, either used alone or with the compatible remote microphone
First competitor hearing aid, either used alone or with compatible remote microphone
Second competitor hearing aid, either used alone or with compatible remote microphone
|
|
Experimental: Device A first, than Device B, then Phonak devices
Participants fit and tested with Device A first, than Device B, then Phonak devices
|
Phonak hearing aid, either used alone or with the compatible remote microphone
First competitor hearing aid, either used alone or with compatible remote microphone
Second competitor hearing aid, either used alone or with compatible remote microphone
|
|
Experimental: Device B, than Phonak devices, than Device A
Participants fit and tested with Device B first, than Phonak devices, then Device A
|
Phonak hearing aid, either used alone or with the compatible remote microphone
First competitor hearing aid, either used alone or with compatible remote microphone
Second competitor hearing aid, either used alone or with compatible remote microphone
|
|
Experimental: Device B first, then Device A, then Phonak devices
Participants fit and tested with Device B first, then Device A, then Phonak devices
|
Phonak hearing aid, either used alone or with the compatible remote microphone
First competitor hearing aid, either used alone or with compatible remote microphone
Second competitor hearing aid, either used alone or with compatible remote microphone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AZ Bio Sentence Test
Time Frame: Visit 2, Day 2 of study
|
Validated test of speech intelligibility in which participants repeat as many words as they can from a presented list of 20 sentences.
Words correct are calculated as a percent correct from the total number of words presented.
Higher percentages mean better speech intelligibility.
|
Visit 2, Day 2 of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 25, 2026
Primary Completion (Actual)
April 21, 2026
Study Completion (Actual)
April 21, 2026
Study Registration Dates
First Submitted
March 24, 2026
First Submitted That Met QC Criteria
March 24, 2026
First Posted (Actual)
March 30, 2026
Study Record Updates
Last Update Posted (Actual)
May 29, 2026
Last Update Submitted That Met QC Criteria
May 27, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRF-36299
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
Yes
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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