WithdrawnNot Applicable

Objective Measurement of Hearing Aid Benefit

Stopped: This study did not receive funding

0Started 2022-06

Plain-language summary

Hearing loss is a critical health concern in the rapidly aging population, affecting approximately 22 million older individuals in the United States. Yet, only 30% of individuals who would benefit from the use of hearing aids regularly use them. This project aims to improve the benefit of hearing aids for older adults through incorporation of objective neural measures to assess effects of hearing aid algorithms.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aims 1 and 2 age ranges: 18-35 and 60-75 * Aim 3 age range: 50 to 85 * Aims 1 and 2 hearing levels: 1) Normal hearing thresholds defined as pure-tone thresholds ≤ 20 decibel (dB) hearing level (HL) from 125 to 4000 Hz and ≤ 30 dB HL at 6000 and 8000 Hz bilaterally, or 2) Mild to moderate sensorineural hearing loss defined as thresholds within 5 dB of 30 dB HL at 500 Hz, 50 dB HL at 1000 and 2000 Hz, and 60 dB HL at 4000 Hz. * Aim 3 hearing level: Symmetric hearing thresholds with no interaural difference ≥ 15 dB HL at ≥ 2 frequencies. * Intelligent Quotients ≥ 85 based on the Wechsler Abbreviated Scale of Intelligence (Psychological Corp., New York) * Scores ≥ 24 on the Montreal Cognitive Assessment Exclusion Criteria: * Neurological disorders * Middle ear pathology * Nonnative English speakers

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neural response fidelity

Timeframe: Immediately post-treatment

Trial details

NCT IDNCT04431622

SponsorUniversity of Maryland, College Park

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

View on ClinicalTrials.gov More Auditory Perceptual Disorders trials