Notched-noise hearing devices to reduce ringing in the ears
Notched Noise Therapy for Suppression of Tinnitus: A Randomized Controlled Trial
This study will test whether wearing hearing-device-delivered notched noise or broadband noise can reduce tinnitus loudness and bother for Veterans with constant tinnitus and some hearing loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04661995 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares continuous "immersion" delivery of notched noise through ear-level devices against broadband noise and hearing-aid amplification alone in Veterans with constant tinnitus and measurable hearing loss. Participants will be fitted with specialized hearing devices and randomized to one of the intervention arms, with the notched frequency customized using a tinnitus pitch match. Outcomes include changes in tinnitus loudness and functional impact measured by behavioral instruments (for example, the Tinnitus Functional Index) and physiological measures over scheduled follow-up visits. The approach emphasizes prolonged background sound exposure rather than brief daily sessions to promote neural remodeling thought to underlie tinnitus suppression.
Who should consider this trial
Good fit: Ideal candidates are Veterans with constant unilateral or bilateral tinnitus, a tinnitus pitch between 2–10 kHz, a Tinnitus Functional Index score of at least 25, at least one air-conduction threshold ≥40 dB HL, MMSE ≥24, no active middle-ear disease, and ability to participate in English.
Not a fit: Patients with very poor hearing (two or more thresholds >70 dB HL), significant conductive hearing loss, intermittent tinnitus, tinnitus pitch outside 2–10 kHz, or who cannot travel to the study site are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce perceived tinnitus loudness and its impact on daily life and provide an evidence-based, accessible treatment option for Veterans.
How similar studies have performed: Prior small studies have reported benefits from notched-noise approaches, but evidence is limited and continuous 'immersion' delivery like this is less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Candidates must meet the following inclusion criteria to qualify: * Veteran * no active middle-ear disease * at least one air conduction hearing threshold of 40 dB HL or worse in each ear between .25-8 kHz as measured at the first study visit * unilateral or bilateral constant tinnitus * index score on the Tinnitus Functional Index (TFI) of at least 25 (out of a maximum score of 100) * a score of 24 or higher on the Mini Mental State Exam (MMSE) * a tinnitus pitch match between 2-10 kHz (and achieve desired level of precision as described below in 3.3 Study Procedures, Tinnitus Psychoacoustic Assessment) * demonstrates understanding of the requirements of the study * motivated and capable of participating (including ability to communicate in English) Exclusion Criteria: The following exclusion criteria will be used: * two or more hearing thresholds exceeding 70 dB HL * significant conductive hearing loss-defined as an air-bone gap of 15 dB at more than two frequencies in one ear, or an air-bone gap greater than 15 dB at any one frequency * suspicion of secondary (somatic) tinnitus, Meniere's disease, or tinnitus potentially related to temporo-mandibular disorder or whiplash (any of which can be ruled out with an examination by an appropriate physician) * any mental, emotional, or health conditions that would preclude full study participation
Where this trial is running
Durham, North Carolina
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Candice Manning Quinn, PhD AuD — Durham VA Medical Center, Durham, NC
- Study coordinator: Candice M Quinn, PhD AuD
- Email: Candice.Quinn@va.gov
- Phone: (919) 286-0411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.