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NCT Number: NCT07824115

The Hear Clear Study

The purpose of this study is to determine if hearing aid use helps adults with "normal" hearing on clinical hearing tests (i.e., pure-tone audiogram), but who report hearing trouble in everyday life. Another purpose is to understand what factors and hearing aid features provide the most help for these people.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders 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

Duke University Medical Center, Durham, North Carolina, United States

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About this study

Participants will be randomly assigned to a hearing aid group and asked to wear a pair of hearing aids with a certain setting for 4 weeks, take a 4-week break, then wear hearing aids with a different setting for 4 weeks. Participants will complete several hearing-related assessments before and after each trial of hearing aids and share their experiences with each hearing aid setting. This study includes four research visits at a research laboratory at Duke University or The Ohio State University.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Are adults (≥18 years) presenting with "normal hearing" (pure-tone thresholds ≤25 dB HL from 250-4000 Hz) but hearing trouble (≥20 points on RHHI questionnaire)
  • Are willing to try amplification (i.e., hearing aids) for the first time
  • Can Read/write in American English
  • Have access to email, internet, and phone

Exclusion criteria

  • Participants with self-reported otologic history (e.g., ear surgery, ototoxic medications, middle-ear dysfunction, holes in ear drums)
  • Have moderate to severe traumatic brain injury
  • Have bothersome tinnitus as their primary complaint
  • Have a health condition that would interfere with study participation (e.g., dementia/cognitive disorder, blindness)
  • Prior hearing aid use

Treatment and study plan

Signal-to-Noise Ratio Enhancement (SNR+)

Other

Participants will be randomly assigned to either the open dome or closed dome group (Factor 1). Participants will then obtain their first treatment arm with a random assignment of either an SNR neutral (SNR-) or SNR enhanced (SNR+) hearing aid fitting (Factor 2). They will return to the lab for testing prior to crossing over to the second arm (the other SNR configuration: SNR- or SNR+).

The SNR+ setting contains features to improve the signal-to-noise ratio of the sound to optimize speech over noise through the hearing aids.

Signal-to-Noise Ratio Neutral (SNR-)

Other

Participants will be randomly assigned to either the open dome or closed dome group (Factor 1). Participants will then obtain their first treatment arm with a random assignment of either an SNR neutral (SNR-) or SNR enhanced (SNR+) hearing aid fitting (Factor 2). They will return to the lab for unaided baseline testing prior to crossing over to the second arm (the other SNR configuration: SNR- or SNR+).

The SNR- setting contains focuses on improving audibility of sounds through the hearing aids.

Primary outcomes

  1. Revised Hearing Handicap Inventory (RHHI)

    Time frame: Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)

    18-item questionnaire that assesses self-perceived hearing difficulty associated with social and emotional situations and is considered a hearing-related quality of life measure. Higher scores indicate MORE hearing difficulty. Administered unaided and aided. Scores range from 0 - 72.

Secondary outcomes

  1. Abbreviated Profile of Hearing Aid Benefit (APHAB)

    Time frame: Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)

    24-item questionnaire used to assess hearing problems in various listening environments (e.g., quiet, background noise, reverberation, and aversiveness to sound). Higher scores indicate greater hearing problems. Administered unaided and aided. Scores range from 1% to 99%.

  2. Words in Noise (WIN) Test

    Time frame: Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)

    35-word recognition in noise test with 5 words at each of the 7 signal-to-noise ratios that go from 24 dB SNR to 0 dB SNR in 4-dB decrements. The noise (six talker babble) is held constant with the level of the words varying to make up the SNRs. Listener repeats words in background noise of talkers where the words get progressively softer. Higher scores indicate more trouble hearing in noise. Administered unaided and aided. Scores range from 0dB to 24dB.

Study contacts

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

Jenny L Norris, MA

CONTACT

[email protected]

919-681-2137

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Hearing Aid Benefit in Adults With Self-Reported Hearing Difficulty Yet Normal Pure-Tone Audiograms (Duke sIRB)

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Sep 17, 2026
Registry last updated
Sep 21, 2026

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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