NCT07824115

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
41mo left

Started Jan 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

3.3 years

First QC Date

September 11, 2026

Last Update Submit

September 16, 2026

Conditions

Hearing Loss

Keywords

normal pure-tone hearingcomplaints of hearing difficultyhearing aidsnormal hearingnear-normal hearingauditory processing

Outcome Measures

Primary Outcomes (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.

    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)

  • Abbreviated Profile of Hearing Aid Benefit (APHAB)

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

  • Words in Noise (WIN) Test

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

Study Arms (2)

Open-dome receiver-in-canal hearing aids

EXPERIMENTAL

Air-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.

Other: Signal-to-Noise Ratio Enhancement (SNR+)Other: Signal-to-Noise Ratio Neutral (SNR-)

Closed-dome receiver-in-canal hearing aids

EXPERIMENTAL

Air-conduction receiver-in-canal (RIC) hearing aids with closed domes, which have solid rubber with tiny or no vents to seal the ear.

Other: Signal-to-Noise Ratio Enhancement (SNR+)Other: Signal-to-Noise Ratio Neutral (SNR-)

Interventions

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.

Closed-dome receiver-in-canal hearing aidsOpen-dome receiver-in-canal 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.

Closed-dome receiver-in-canal hearing aidsOpen-dome receiver-in-canal hearing aids

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (3)

  • 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.

    PMID: 29863462BACKGROUND

  • 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.

    PMID: 32603602BACKGROUND

  • 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.

    PMID: 37553897BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sherri L Smith, Au.D., Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny L Norris, MA

CONTACT

919-681-2137jenny.l.norris@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Investigators will share the de-identified analytic dataset and associated metadata as required by NIH policy.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
1 year after the main publication or as required by NIH policy
Access Criteria
Researchers interested in the study analytic dataset will request permission for use with justification for access.

Locations

US(2)