Skip to main content
Clinical Trials/NCT06746038
NCT06746038
Not Yet Recruiting
N/A

Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

Sonova AG1 site in 1 country10 target enrollmentJanuary 15, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sensorineural Hearing Loss
Sponsor
Sonova AG
Enrollment
10
Locations
1
Primary Endpoint
NASA Task Load Index (NASA-TLX)
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.

Detailed Description

This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.

Registry
clinicaltrials.gov
Start Date
January 15, 2025
End Date
March 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sonova AG
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Meets requirements outlined on Lyric Candidacy Form
  • Current Lyric hearing instrument user
  • 18 years of age or older at time of enrollment in the study
  • Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
  • Good understanding (read/write/speak) of the English language
  • Willingness to comply with all study requirements

Exclusion Criteria

  • Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)
  • Difficulty understanding/reading instructions when corrected for vision loss
  • Impairments that would restrict participation in any of the evaluations
  • Ear health conditions present at baseline that prevent immediate device replacement
  • Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol

Outcomes

Primary Outcomes

NASA Task Load Index (NASA-TLX)

Time Frame: Day 1 of 1 day study

A raw score on six demensions (mental demand, physical demand, temporal demand, frustration, effort, performance) on a scale from 1 (low/good) to 20 (high/poor). A higher score indicates higher levels of subjective effort.

Secondary Outcomes

  • AZBio Speech in noise testing(Day 1 of 1 day study)

Study Sites (1)

Loading locations...

Similar Trials