Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

Not Applicable

Not yet recruiting

• Conditions: Sensorineural Hearing Loss

• Registration Number: NCT06746038
• Lead Sponsor: Sonova AG

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Study Start: 2025-01-15
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
NASA Task Load Index (NASA-TLX)	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 Outcome Measures

Name	Time	Method
AZBio Speech in noise testing	Day 1 of 1 day study	The percentage of words correctly repeated by the participant when listening to sentences played from a front speaker at a certain dB level, while background noise is presented simultaneously from four corner speakers. A higher percentage indicates better speech understanding in noise.

Trial Locations

Locations (1)

The Woodlands Hearing Center; 🇺🇸 Shenandoah, Texas, United States