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NCT Number: NCT06746038

Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

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.

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Key information

Conditions

Sensorineural Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Woodlands Hearing Center

Shenandoah, Texas, 77384, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended Wear Hearing Aid

Device

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.

Other names: Lyric4

Primary outcomes

  1. 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

  1. AZBio Speech in noise testing

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Manager

CONTACT

[email protected]

630-821-5000

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • The Woodlands Hearing Center

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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