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Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

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Sonova

Status

Not yet enrolling

Conditions

Sensorineural Hearing Loss

Treatments

Device: Extended Wear Hearing Aid

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT06746038
SRF-469

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Experimental Group
Experimental group
Description:
Participants who are fit with study Lyric devices and tested on speech intelligibility and effort using two different fitting algorithms
Treatment:
Device: Extended Wear Hearing Aid

Trial contacts and locations

1

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Central trial contact

Study Manager

Data sourced from clinicaltrials.gov

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