Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extended Wear Hearing Aid.
- Who it may be relevant to
- Registry conditions: Sensorineural Hearing Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Extended Wear Hearing Aid
Extended wear hearing aid means that the device is worn 24 hours per day, 7 days a week for months at a time. However, this study will only fit devices on participants for one testing session lasting 2 hours.
Primary outcome measures
- NASA Task Load Index (NASA-TLX) [Time frame: Day 1 of 1 day study]
Secondary outcome measures (1)
- AZBio Speech in noise testing [Time frame: Day 1 of 1 day study]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Woodlands Hearing Center — Shenandoah
Identifiers
NCT: NCT06746038 · SRF-469