Notched Noise Therapy for Suppression of Tinnitus

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 3, 2020

Keywords

ClinConnect Summary

This study is testing whether a special sound therapy delivered through hearing aids can help reduce tinnitus (ringing in the ears) in veterans who also have hearing loss. Participants will be randomly assigned to one of three groups: (1) hearing aid with Notched Noise Therapy (sound shaped to avoid the person’s tinnitus pitch), (2) hearing aid with broadband white noise, or (3) hearing aid with amplification only. The goal is to see which method best reduces the impact of tinnitus and changes in loudness, using a well-validated questionnaire.

About who can join: adults 18 and older who are veterans with tinnitus and a certain level of hearing loss. They must have at least one ear with a hearing threshold of 40 dB HL or worse in the 0.25–8 kHz range, constant tinnitus, a Tinnitus Functional Index (TFI) score of 25 or higher, MMSE of 24 or higher, and a tinnitus pitch between 2–10 kHz. They must be able to communicate in English and not have active middle-ear disease or other conditions that would interfere with participation. The trial plans to enroll 108 people at the Durham VA Medical Center, with visits at baseline, 4 weeks, 8 weeks (during therapy), and a follow-up at 12 weeks. All participants wear the study-hearing aids most or all waking hours for 8 weeks, and outcomes include the TFI score, tinnitus loudness matching, and, for a small subgroup, brain-recording tests to study brain responses. The study is currently enrolling by invitation and is expected to finish around May 2026.

Gender

ALL

Eligibility 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