Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus

NCT03904264 | Completed Results FDA Device

• 1 other identifier: C3196-P
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Tinnitus - defined as ringing, humming, or other sounds in the ears or head - is a very common problem for Veterans. Hearing aids that deliver low-level amplification are being used by audiologists to help people with tinnitus who also have normal hearing. However, there is a lack of research evidence showing that this practice is effective. Despite this fact, the practice clearly is spreading. Reports from audiologists in the field as well as research presentations refer to hearing aids being used in this way. Use of hearing aids has been shown to reduce distress from tinnitus for people with hearing loss. Additionally, the use of external sound to help reduce the impact of tinnitus has been shown to be effective. There is clearly a gap in the research regarding the use of hearing aids as a therapeutic method to manage tinnitus when hearing is considered normal. This study will obtain pilot data evaluating people with normal hearing and bothersome tinnitus to find out whether low-level amplification through hearing aids may provide benefit.

Conditions

Tinnitus; Hearing Aids; Normal Hearing

Keywords

tinnitus; hearing aids; normal hearing

Outcome Measures

Primary Outcomes (1)

• Tinnitus Functional Index Change

  The Tinnitus Functional Index (TFI) is a statistically validated measure of the functional impact of tinnitus. The TFI was developed to be sensitive to changes in function as a result of intervention for tinnitus. Range is 0 - 100, higher numbers indicates greater level of distress and functional impact.

  The Tinnitus Functional index will be administered at baseline, 2-3 weeks after baseline, and 3 months after baseline

Study Arms (2)

Hearing Aid Study

EXPERIMENTAL

Measure the reduction in tinnitus handicap when mild amplification through receiver-in-the-canal hearing aids is provided to adults with bothersome tinnitus and normal hearing thresholds.

Device: Receiver in the canal (RIC) hearing aids

VA Clinician Interviews

NO INTERVENTION

Document the opinions, procedures, and rationale used clinically to make decisions regarding fitting mild amplification for tinnitus on Veterans with bothersome tinnitus and normal hearing thresholds. The data for this arm of the study will be collected via telephone interview.

Interventions

Receiver in the canal (RIC) hearing aids DEVICE

The RIC hearing aids fitted to subjects in arm 1 of the study will be manufactured by Widex.

Hearing Aid Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a score of 5 or greater on section A the Tinnitus and Hearing Survey during the telephone screening; and
• air conduction hearing thresholds of 25 dB HL or better from .25 kHz through 4 kHz bilaterally as measured at the first study visit;
• must not be a current hearing aid user; and
• capable of consenting and participating (including ability to communicate in English).
• simply VA audiologists willing to participate.

You may not qualify if:

• an air conduction hearing threshold greater than 25 dB HL from .25 kHz through 4 kHz;
• 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 20 dB at any one frequency;
• suspicion of secondary (somatic) tinnitus, or Meniere's disease (either of which can be ruled out with an examination by an appropriate physician);
• currently a hearing aid user; or
• any mental, emotional, or health conditions that would preclude full study participation.
• not an audiologist
• not a VA employee.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Results Point of Contact

• Title: Tara Zaugg, AuD / CRH REC Consultant, VISN 20 and REC ICC Clinical Lead, VISN 20
• Organization: Department of Veterans Affairs

tara.zaugg@va.gov

208-422-1000

Study Officials

• Tara Zaugg, AuD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: For this pilot study 20 eligible adults with bothersome tinnitus and normal hearing thresholds from audiometric frequencies .25 kHz through 4 kHz will be provided with hearing aids. Eligible adults with tinnitus and normal hearing are the only participants for whom an intervention will be provided as part of the study. Fifteen VA clinical audiologists will be interviewed to document opinions, procedures, and rationale used clinically to make decisions regarding fitting mild amplification for tinnitus on Veterans with bothersome tinnitus and normal hearing thresholds. No intervention will be provided to the participating audiologists.

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: February 24, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 21, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)