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Compression Headphone Study

Primary Purpose

Hearing Loss

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Receiver-in-canal hearing aid 1 default
Receiver-in-canal hearing aid 2
Receiver-in-canal hearing aid 1 strategy 1
Receiver-in-canal hearing aid 1 strategy 2
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sonova Innovation Centre Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

No Intervention

Arm Label

Receiver-in-canal hearing aid 1 default

Receiver-in-canal hearing aid 2

Receiver-in-canal hearing aid 1 strategy 1

Receiver-in-canal hearing aid 1 strategy 2

No device

Arm Description

Receiver-in-canal hearing aid with current default compression strategy

Receiver-in-canal hearing aid from a different manufacturer with default compression strategy

Receiver-in-canal hearing aid with modified compression strategy 1

Receiver-in-canal hearing aid with modified compression strategy 2

Stimuli recordings without hearing aid

Outcomes

Primary Outcome Measures

Sound quality rating
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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2021
Last Updated
September 28, 2021
Sponsor
Sonova AG
Collaborators
Sonova Canada Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04882709
Brief Title
Compression Headphone Study
Official Title
Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
No reliable differences across conditions, unacceptable test-retest reliability
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
September 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Sonova Canada Inc.

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Receiver-in-canal hearing aid 1 default
Arm Type
Active Comparator
Arm Description
Receiver-in-canal hearing aid with current default compression strategy
Arm Title
Receiver-in-canal hearing aid 2
Arm Type
Active Comparator
Arm Description
Receiver-in-canal hearing aid from a different manufacturer with default compression strategy
Arm Title
Receiver-in-canal hearing aid 1 strategy 1
Arm Type
Experimental
Arm Description
Receiver-in-canal hearing aid with modified compression strategy 1
Arm Title
Receiver-in-canal hearing aid 1 strategy 2
Arm Type
Experimental
Arm Description
Receiver-in-canal hearing aid with modified compression strategy 2
Arm Title
No device
Arm Type
No Intervention
Arm Description
Stimuli recordings without hearing aid
Intervention Type
Device
Intervention Name(s)
Receiver-in-canal hearing aid 1 default
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Receiver-in-canal hearing aid 2
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Receiver-in-canal hearing aid 1 strategy 1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Receiver-in-canal hearing aid 1 strategy 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sound quality rating
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyu Qian, PhD
Organizational Affiliation
Sonova Canada Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonova Innovation Centre Toronto
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L1J3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Compression Headphone Study

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