Lab Evaluation of Novel Hearing Aid Coupling Method

March 10, 2025 updated by: Sonova AG
Evaluation of different hearing aid coupling methods including two states of a novel coupling method and two traditional coupling methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An important decision in the fitting of hearing aids is the selection of the coupling method. Examples of coupling options include universal rubber domes and custom earmolds. When selecting a coupling method, the degree of venting must be considered.

Venting refers to an opening in the coupling method to allow for the sound transmission from the tympanic membrane to the external environment. The degree of venting has a significant impact on the hearing aid user's experience. More closed (or more occluded) coupling means the vent is smaller or non-existent. Occluded fittings allow for more low-frequency amplification, which improves hearing aid performance like directionality, noise reduction and streaming sound quality. However, occluded fittings lead to complaints of the occlusion effect, in which users complain of their own voice as sounding "boomy" and can also lead to a build-up of pressure in the ear canal which users may find uncomfortable. To relieve the occlusion effect and pressure build-ups, more vented (sometimes called open) couplings can be used by allowing low-frequency sounds to leave the ear. Despite a degradation in hearing aid outcomes like directionality, noise reduction and streaming sound quality, open fits are typically preferred for speech quality and own-voice perception - at least for hearing aid users with milder losses and near-normal thresholds at low frequencies.

The fact that two coupling options are associated with two different outcomes means that hearing aid practitioners need to make an important trade-off. Either their patient will enjoy the full breadth of the hearing aid's signal processing potential (via a more occluded fit) or their patient will enjoy better own-voice perception and relief of air pressure in the ear canal(via a more open fit). A coupling method that allows for the best of both options is left to be desired.

A recent development in coupling methods has allowed us to take advantage of both open and closed fittings in a single solution. More occluded coupling allows for more low-frequency amplification which improves hearing aid performance in areas such as directionality, noise reduction, and streaming sound quality. Whereas, open coupling options reduces complaints of the occlusion effect and is preferred for speech quality and own-voice perception by hearing aid users with milder losses. This novel coupling method will function as both an open and closed fitting depending on the environment the listener is in. State 1 is dedicated to loud environments where the listener can take advantage of noise management solutions and for streaming so they can enjoy better sound quality. State 2 is dedicated to quieter environments where the listener can enjoy better physical comfort and own-voice naturality.

This novel coupling method should theoretically exploit the benefits of both open and closed coupling methods. This study is designed to see how this novel coupling method compares to traditional domes and how this coupling method performs in various listening situations.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6G1H1
        • Western University - National Centre for Audiology

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

Yes

Description

Inclusion Criteria:

  • Hearing aid candidate
  • Meets the fitting requirements for novel and traditional coupling options
  • Healthy outer ear - no visible congenital or traumatic deformity
  • Symmetrical hearing loss
  • No air-bone gap greater than 10 dB at 500, 1000, 2000, and 4000 Hz
  • Ability to answer questions and repeat sentences
  • No history of problematic tinnitus or pain/discomfort from loud sounds
  • No history of active drainage from the ears in the past 90 days
  • Informed consent as documented by signature.

Exclusion Criteria:

  • Limited mobility (not able to attend scheduled visits)
  • 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
  • Known psychological problems.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids with various coupling methods. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
Device: Recordings of Hearing Aids with Open Domes
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled to open domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Device: Recordings of Hearing Aids with Closed Domes
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with closed domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Device: Recordings of Hearing Aids with Novel State 1
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Device: Recordings of Hearing Aids with Novel State 2
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sound Quality Ratings While Streaming
Time Frame: 60 minutes

Hearing aid recordings of different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will rate and compare sound quality attributes between them.

Ratings will be made on a scale where 0 would the minimum value and 100 would be the maximum value.

Fullness: Higher scores indicate that participants found the recording to be fuller (thicker/richer sound). Higher scores indicate a better outcome.

Sharpness: Higher scores indicate that participants found the recording to be sharper (thinner/more shrill). Lower scores indicate a better outcome.

Overall Impression: Higher scores indicate that participants had an increased preference towards the recording when compared to the other recordings. Higher scores indicate a better outcome.
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Situational Preference Ratings
Time Frame: 60 Minutes

Hearing aid recordings of different listening situations through different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will indicate preferences between different recordings.

Ratings will be made on a scale where 0 would the minimum value and 100 would be the maximum value. Higher scores indicate increased preferred sound quality.

Higher scores will indicate that participants had an increased preference towards that recording when compared to the other recordings. In this measure, on
60 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

Collaborators

Western University, Canada
Sonova Canada Inc.

Investigators

  • Principal Investigator: Jinyu Qian, PhD, Sonova AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 7, 2023

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

November 20, 2023

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-1082

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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