Status:
COMPLETED
Wear-Time Trial for Self-Fitting Hearing Aid
Lead Sponsor:
GN Hearing A/S
Collaborating Sponsors:
Northwestern University
Sertoma Speech and Hearing Center
Conditions:
Hearing Loss, Sensorineural
Eligibility:
All Genders
18-75 years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- 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
- Hearing outside of limits noted above
- Self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)
Key Trial Info
Start Date :
June 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04823494
Start Date
June 18 2021
End Date
December 20 2021
Last Update
May 11 2022
Active Locations (2)
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1
Sertoma Speech and Hearing Center
Palos Hills, Illinois, United States, 60465
2
Vanderbilt University
Nashville, Tennessee, United States, 37235