Compression Headphone Study

Hearing Loss Clinical Trial

Official title:

Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04882709
• Other study ID #: 365
• Status: Terminated
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: September 2, 2021

Study information

• Verified date: July 2021
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 2, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Sonova Innovation Centre Toronto	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Sonova Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour