Functional Hearing Difficulties
Conditions
Keywords
normal pure-tone hearing, complaints of hearing difficulty, hearing aids, normal hearing, near-normal hearing, auditory processing
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.
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.
Interventions
OTHERSignal-to-Noise Ratio Enhancement (SNR+)
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.
OTHERSignal-to-Noise Ratio Neutral (SNR-)
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.
Sponsors
Duke University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Hearing Handicap Inventory (RHHI) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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%. |
| 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) | 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. |
Countries
United States
Contacts
CONTACTJenny L Norris, MA
PRINCIPAL_INVESTIGATORSherri L Smith, Au.D., Ph.D.
Duke University
Outcome results
None listed