CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Hearing aidsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04823494
NCT04823494N/ACompleted
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Protocol for Self-Fitting Hearing Aid Wear-Time Trial for Listeners With Mild to Moderate Hearing Loss

GN Hearing A/S·interventional·Posted Mar 30, 2021·Updated May 11, 2022

In Brief

A clinical study evaluating Hearing aids for Hearing Loss, Sensorineural. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Loss, Sensorineural
CountriesUnited States
CollaboratorsNorthwestern University, Sertoma Speech and Hearing Center, Vanderbilt University

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 30, 2021
Enrollment StartJun 18, 2021
Primary CompletionSep 30, 2021
Study CompletionDec 20, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.3 years ago

Interventions

Hearing aidsdevice

Earbud style hearing aids fit to both ears