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Hearing LossNCT07824115

The Hear Clear Study

A study testing Signal-to-Noise Ratio Enhancement (SNR+) and Signal-to-Noise Ratio Neutral (SNR-) in people with Hearing Loss, run by Duke University at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Loss
What is being tested?
Signal-to-Noise Ratio Enhancement (SNR+) and Signal-to-Noise Ratio Neutral (SNR-)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
2 sitesUnited States
Study dates
Jan 2027to May 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jenny L Norris, MA contact

919-681-2137

jenny.l.norris@duke.edu

United States2 sites

  • The Ohio State University

    Columbus, Ohio, 43210

    Christina M Roup, Ph.D., 614-247-8614, roup.2@osu.edu

    Christina M Roup, Ph.D.

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Jenny L Norris, MA, 919-681-2137, jenny.l.norris@duke.edu

    Sherri L Smith, Au.D., Ph.D., 919-613-1110, sherri.smith@duke.edu

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Conditions
Hearing Loss
Being tested
Signal-to-Noise Ratio Enhancement (SNR+), Signal-to-Noise Ratio Neutral (SNR-)
Keywords
normal pure-tone hearing, complaints of hearing difficulty, hearing aids, normal hearing, near-normal hearing, auditory processing
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07824115
Study groupRoleWhat they receive
Open-dome receiver-in-canal hearing aidsExperimentalAir-conduction receiver-in-canal (RIC) hearing aids with open domes, which have holes or vents that let natural sound and air pass into the ear canal.
Receives: Other: Signal-to-Noise Ratio Enhancement (SNR+); Other: Signal-to-Noise Ratio Neutral (SNR-)
Closed-dome receiver-in-canal hearing aidsExperimentalAir-conduction receiver-in-canal (RIC) hearing aids with closed domes, which have solid rubber with tiny or no vents to seal the ear.
Receives: Other: Signal-to-Noise Ratio Enhancement (SNR+); Other: Signal-to-Noise Ratio Neutral (SNR-)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Revised Hearing Handicap Inventory (RHHI)

    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.

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

Secondary outcomes (2)

  1. Abbreviated Profile of Hearing Aid Benefit (APHAB)

    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%.

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

  2. Words in Noise (WIN) Test

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionMay 2030 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07824115
Sponsor's protocol ID
Pro00120285
Other IDs
1R01DC022584-01A1
Status last verified
Sep 2026
First submitted
11 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Investigators will share the de-identified analytic dataset and associated metadata as required by NIH policy.

Publications

  • Roup CM, Post E, Lewis J. Mild-Gain Hearing Aids as a Treatment for Adults with Self-Reported Hearing Difficulties. J Am Acad Audiol. 2018 Jun;29(6):477-494. doi: 10.3766/jaaa.16111.

    PubMed 29863462

  • Singh J, Doherty KA. Use of a Mild-Gain Hearing Aid by Middle-Age Normal-Hearing Adults Who Do and Do Not Self-Report Trouble Hearing in Background Noise. Am J Audiol. 2020 Sep 3;29(3):419-428. doi: 10.1044/2020_AJA-19-00051. Epub 2020 Jun 30.

    PubMed 32603602

  • Mealings K, Valderrama JT, Mejia J, Yeend I, Beach EF, Edwards B. Hearing Aids Reduce Self-Perceived Difficulties in Noise for Listeners With Normal Audiograms. Ear Hear. 2024 Jan-Feb 01;45(1):151-163. doi: 10.1097/AUD.0000000000001412. Epub 2023 Aug 9.

    PubMed 37553897

Questions about this trial

What is this clinical trial studying?

A study testing Signal-to-Noise Ratio Enhancement (SNR+) and Signal-to-Noise Ratio Neutral (SNR-) in people with Hearing Loss, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jenny L Norris, MA (919-681-2137, jenny.l.norris@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07824115, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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