Compression Headphone Study

September 28, 2021 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 will be randomized.

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

  • Canada
    • 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

Genders Eligible for Study

All

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
Active Comparator: Receiver-in-canal hearing aid 1 default
Receiver-in-canal hearing aid with current default compression strategy
Device: Receiver-in-canal hearing aid 1 default
A receiver-in-canal hearing aid developed by the Study Sponsor used with the default settings as specified in the Study Sponsor's fitting software.
Active Comparator: Receiver-in-canal hearing aid 2
Receiver-in-canal hearing aid from a different manufacturer with default compression strategy
Device: Receiver-in-canal hearing aid 2
A receiver-in-canal hearing aid developed by another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software.
Experimental: Receiver-in-canal hearing aid 1 strategy 1
Receiver-in-canal hearing aid with modified compression strategy 1
Device: Receiver-in-canal hearing aid 1 strategy 1
A receiver-in-canal hearing aid developed by the Study Sponsor used with a modified compression strategy that is expected to improve the sound quality.
Experimental: Receiver-in-canal hearing aid 1 strategy 2
Receiver-in-canal hearing aid with modified compression strategy 2
Device: Receiver-in-canal hearing aid 1 strategy 2
A receiver-in-canal hearing aid developed by the Study Sponsor used with a modified compression strategy that is expected to improve the sound quality.
No Intervention: No device
Stimuli recordings without hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sound quality rating
Time Frame: 1 hour
The sound quality rating will be conducted via an online questionnaire that contains sound samples participants listen to and rate subsequently. Dimensions rated are: Overall Preference, Reverberation, Sound Source Localization, Sound Source Separation, and Timbral Balance.
1 hour

Collaborators and Investigators

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

Sponsor

Sonova AG

Collaborators

Sonova Canada Inc.

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)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

July 1, 2021

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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