Clinical trial NCT04823494: Wear-Time Trial for Self-Fitting Hearing Aid
Official title: Protocol for Self-Fitting Hearing Aid Wear-Time Trial for Listeners With Mild to Moderate Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: GN Hearing A/S
Sponsor class: INDUSTRY
Collaborators: name: Northwestern University
name: Sertoma Speech and Hearing Center
name: Vanderbilt University
First posted: 2021-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This document describes a clinical validation study for a double-blind repeated-measures comparative study of the Great Nordic (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.


Eligibility criteria: Inclusion Criteria:

* Mild-to-moderate bilateral sensorineural hearing loss (thresholds from 250 - 8000 Hz less than 60 decibels Hearing Level (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)

Primary outcomes:
measure: Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: 10-14 days
Secondary outcomes:
measure: Quick Speech in Noise Test (QuickSIN)
timeFrame: Measurement after 10-14-day wear time for each fit.
Other outcomes:
Locations:
city: Palos Hills
country: United States
facility: Sertoma Speech and Hearing Center
state: Illinois
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Todd Ricketts, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Sumitrajit Dhar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
citation: Killion MC, Niquette PA, Gudmundsen GI, Revit LJ, Banerjee S. Development of a quick speech-in-noise test for measuring signal-to-noise ratio loss in normal-hearing and hearing-impaired listeners. J Acoust Soc Am. 2004 Oct;116(4 Pt 1):2395-405. doi: 10.1121/1.1784440.