By InvitationNot Applicable

Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus

United States100 participantsStarted 2025-07-07

Plain-language summary

This study is a Post-Market Clinical Investigation whose primary purpose is to evaluate hearing aid amplification and tinnitus masker performance for individuals with hearing loss and tinnitus. There are two primary hypotheses that will be assessed in this study: The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. The use of well-fit amplification in conjunction with a tinnitus masker improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. Participants will be fit with hearing aids for 6 months and a tinnitus masker will be activated at the 3-month mark of the study. Outcome measures will evaluate device performance and participant benefit from the devices throughout the study duration.

Who can participate

Age range

18 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: * At least 18 years old Native English speaking (defined that all education was done in English) Bilateral hearing impairment ranging from mild to profound Mild to severe tinnitus Ability to commute to research facility Exclusion Criteria: * Participants will be advised to consult promptly a doctor, preferably an ear specialist such as an ENT, prior to being fit with the study devices, if they display any of the following conditions: Visible deformity of the ear, either congenital or traumatic Fluid, pus, or blood coming out of the ear within the previous 6 months Pain or discomfort in the ear History of excessive ear wax or suspicion that something is in the ear canal Dizziness, either recent or long-standing Sudden, quickly worsening, or fluctuating hearing loss within the previous 6 months Hearing loss or ringing (tinnitus) only in one ear or a noticeable difference in hearing between ears Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz Cognitive impairment Tinnitus with a somatic origin indicating a need for medical treatment Current user of noise masker delivered via a wearable device Hyperacusis or extreme sensitivity to sounds Is employed by the study sponsor

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

Provision of adequate amplification

Timeframe: The time frame of this data collection is at the hearing aid fitting which occurs at the initial fitting (Session 1, day 1). This will occur the first time the participant is seen for the study visits.

Device Oriented Subjective Outcome (DOSO) questionnaire to evaluate perceived benefit

Timeframe: The time frame of this data collection will occur at session 3 (6 weeks), session 4 (12 weeks), and session 7 (24 weeks)

Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire

Timeframe: The time frame of this data collection will occur at session 1(initial fitting, day 1), session 3 (6 weeks), session 4 (12 weeks), and session 7 (24 weeks)

Tinnitus Handicap Inventory (THI) questionnaire

Timeframe: The time frame of this data collection will occur at session 1 (initial fitting, day 1), session 4 (12 weeks), and session 7 (24 weeks)

Tinnitus Functional Index (TFI) questionnaire

Timeframe: This data will be collected at Session 1(day 1), Session 2 (2 weeks), Session 3 (6 weeks), Session 4 (12 weeks), Session 5 (14 weeks), Session 6 (18 weeks), Session 7 (24 weeks).

Trial details

NCT IDNCT07298499

SponsorStarkey Laboratories, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

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