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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phonak device first, then Device A, then Device B
Participants fit and tested with Phonak devices first, then Devices A, then Devices B
Device: Phonak
Phonak hearing aid, either used alone or with the compatible remote microphone
Device: Device A
First competitor hearing aid, either used alone or with compatible remote microphone
Device: Device B
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
Device: Phonak
Phonak hearing aid, either used alone or with the compatible remote microphone
Device: Device A
First competitor hearing aid, either used alone or with compatible remote microphone
Device: Device B
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
Device: Phonak
Phonak hearing aid, either used alone or with the compatible remote microphone
Device: Device A
First competitor hearing aid, either used alone or with compatible remote microphone
Device: Device B
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
Device: Phonak
Phonak hearing aid, either used alone or with the compatible remote microphone
Device: Device A
First competitor hearing aid, either used alone or with compatible remote microphone
Device: Device B
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
Device: Phonak
Phonak hearing aid, either used alone or with the compatible remote microphone
Device: Device A
First competitor hearing aid, either used alone or with compatible remote microphone
Device: Device B
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
Device: Phonak
Phonak hearing aid, either used alone or with the compatible remote microphone
Device: Device A
First competitor hearing aid, either used alone or with compatible remote microphone
Device: Device B
Second competitor hearing aid, either used alone or with compatible remote microphone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sonova AG

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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