N/A N=40 Double-blind Treatment

Wear-Time Trial for Self-Fitting Hearing Aid

Hearing Loss, Sensorineural

Bottom Line

View on ClinicalTrials.gov: NCT04823494 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Aided Abbreviated Profile of Hearing Aid Benefit (APHAB) — 21.35; 22.76 score on a scale — p=<0.025

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hearing aids (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GN Hearing A/S
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)	21.35; 22.76	<0.025 sig
SECONDARY Quick Speech in Noise Test (QuickSIN)	2.19; 2.77	<0.025 sig

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04823494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.