An interventional study of Signal-to-Noise Ratio Enhancement (SNR+) and Signal-to-Noise Ratio Neutral (SNR-) in Hearing Loss, sponsored by Duke University. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 125 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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-)
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-)
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.
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.
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)
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)
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)
Plan to share: Yes — Investigators will share the de-identified analytic dataset and associated metadata as required by NIH policy.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
Start is estimated for Jan 2027; primary completion for May 2030, 40 months later.
Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 40 months is above that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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