Health TrialsbyHealthPanel

The Hear Clear Study

ConditionHearing Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Signal-to-Noise Ratio Enhancement (SNR+)

    Other intervention

    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 intervention

    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.

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: Open-dome receiver-in-canal hearing aidsExperimental treatment 2 interventions
Group B: Closed-dome receiver-in-canal hearing aidsExperimental treatment 2 interventions

Trial outcomes

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.

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)

Secondary outcomes

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%.

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)
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.

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: