Compression Headphone Study

• ClinicalTrials.gov Identifier: NCT04882709
• Recruitment Status: Terminated
• First Posted: May 12, 2021
• Last Update Posted: October 6, 2021
• Sponsor: Sonova AG
• Collaborator: Sonova Canada Inc.
• Information provided by (Responsible Party): Sonova AG

Tracking Information

• First Submitted Date: May 4, 2021
• First Posted Date: May 12, 2021
• Last Update Posted Date: October 6, 2021
• Actual Study Start Date: May 10, 2021
• Actual Primary Completion Date: September 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2021)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Compression Headphone Study
• Official Title: Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: 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.
• 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.
• 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.
• 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.

Study Arms

• Active Comparator: Receiver-in-canal hearing aid 1 default
  Receiver-in-canal hearing aid with current default compression strategy
  Intervention: Device: Receiver-in-canal hearing aid 1 default
• Active Comparator: Receiver-in-canal hearing aid 2
  Receiver-in-canal hearing aid from a different manufacturer with default compression strategy
  Intervention: Device: Receiver-in-canal hearing aid 2
• Experimental: Receiver-in-canal hearing aid 1 strategy 1
  Receiver-in-canal hearing aid with modified compression strategy 1
  Intervention: Device: Receiver-in-canal hearing aid 1 strategy 1
• Experimental: Receiver-in-canal hearing aid 1 strategy 2
  Receiver-in-canal hearing aid with modified compression strategy 2
  Intervention: Device: Receiver-in-canal hearing aid 1 strategy 2
• No Intervention: No device
  Stimuli recordings without hearing aid

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 28, 2021): 12
• Original Estimated Enrollment (submitted: May 11, 2021): 25
• Actual Study Completion Date: September 2, 2021
• Actual Primary Completion Date: September 2, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT04882709
• Other Study ID Numbers: 365
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sonova AG
• Original Responsible Party: Same as current
• Current Study Sponsor: Sonova AG
• Original Study Sponsor: Same as current
• Collaborators: Sonova Canada Inc.

Investigators

• Principal Investigator: Jinyu Qian, PhD; Sonova Canada Inc.

• PRS Account: Sonova AG
• Verification Date: July 2021