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Wear-Time Trial for Self-Fitting Hearing Aid

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ClinicalTrials.gov Identifier: NCT04823494
Recruitment Status : Not yet recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Collaborators:
Northwestern University
Vanderbilt University
Information provided by (Responsible Party):
GN Hearing A/S

Brief Summary:
This document describes a clinical validation study for a double-blind repeated-measures comparative study of the GN self-fitting method to a validated audiology-best-practices method when fitting the GN Self-fitting Hearing Aid, a device intended for persons aged 18-75 years old who have mild-to-moderate hearing loss. A crossover wear-time field trial will be conducted. The focus of the study is on the validity of the self-fitting process used to select appropriate frequency-gain characteristics for the GN Self-fitting Hearing Aid, and the safety and effectiveness of the device.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Device: Hearing aids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Protocol for Self-Fitting Hearing Aid Wear-Time Trial for Listeners With Mild to Moderate Hearing Loss
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pro-Fit
Hearing aids fit by a professional hearing care provider using best practices.
Device: Hearing aids
Earbud style hearing aids fit to both ears

Experimental: Self-Fit
Hearing aids fit by patient.
Device: Hearing aids
Earbud style hearing aids fit to both ears




Primary Outcome Measures :
  1. Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: 10-14 days ]
    A 24-item survey of hearing aid benefit with 7 possible responses for each item


Secondary Outcome Measures :
  1. Quick Speech in Noise test (QuickSIN) [ Time Frame: immediate measurement after 10-14-day wear time ]
    An adaptive measure of sentence recognition in competing speech with 6 sentences (30 keywords) scored as correct or incorrect



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mild-to-moderate bilateral sensorineural hearing loss (thresholds from 250 - 8000 Hz less than 60 dB HL and from 2000 - 8000 Hz, at least one threshold greater than 20 dB HL)
  • Mix of male and female subjects (aiming for a representative balance)
  • Mix of prior hearing-aid use (aiming for 70-80% persons with no prior hearing aid use)
  • 18-75 years old (aiming for primarily 50-70 years old, with avg. age ~65 years)
  • Apple iPhone (iOS 14 compatible or greater, as required for the SELF-FIT app)
  • Able to read and comprehend English
  • Patient willing to provide informed consent

Exclusion Criteria:

  • Hearing outside of limits noted above
  • Self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823494


Contacts
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Contact: Todd Fortune, Ph.D. 763-772-5566 tfortune@gnresound.com

Locations
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United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60209
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
GN Hearing A/S
Northwestern University
Vanderbilt University
Investigators
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Principal Investigator: Todd Ricketts, Ph.D. Vanderbilt University
Principal Investigator: Sumitrajit Dhar, Ph.D. Northwestern University
Publications:
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Responsible Party: GN Hearing A/S
ClinicalTrials.gov Identifier: NCT04823494    
Other Study ID Numbers: X-Men
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases