Wear-Time Trial for Self-Fitting Hearing Aid

GN Hearing

Status

Completed

Conditions

Hearing Loss, Sensorineural

Treatments

Device: Hearing aids

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04823494

X-Men

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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