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

Primary Purpose

Tinnitus, Hearing Aids, Normal Hearing

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receiver in the canal (RIC) hearing aids
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tinnitus focused on measuring tinnitus, hearing aids, normal hearing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion criteria for the Hearing Aid study include:

  • 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).

Inclusion criteria for the VA Clinician Interviews:

-simply VA audiologists willing to participate.

Exclusion Criteria:

Exclusion criteria for the Hearing Aid study include:

  • 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.

Exclusion criteria for the VA Clinician Interviews are:

  • not an audiologist
  • not a VA employee.

Sites / Locations

  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hearing Aid Study

VA Clinician Interviews

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2019
Last Updated
March 9, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03904264
Brief Title
Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus
Official Title
Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Tinnitus - defined as ringing, humming, or other sounds in the ears or head - is the most prevalent service-connected disability among Veterans. Tinnitus affects 10-15% of the adult population. For about 20% of these, tinnitus impacts their lives with respect to sleep disturbance, impaired concentration, and/or emotional reactions. These 20% are the most in need of clinical services. It has been shown that providing amplification via hearing aids for people with hearing loss can also be beneficial in reducing functional effects of tinnitus, presumably because amplifying environmental sounds reduces the contrast between the tinnitus and background sound, allowing the tinnitus to be more easily ignored. There have been increasing reports from the field of audiologists providing hearing aids set to deliver low-gain amplification on patients with bothersome tinnitus who are not otherwise hearing aid candidates, with beneficial outcomes. However, this nontraditional fitting practice has not been formally evaluated, so there is no research evidence to support the practice. It is essential for VA to show evidence supporting such practices to justify the use (and expense) of these devices with patients who otherwise do not qualify to receive hearing aids. The proposed project is a pilot study that would lay the groundwork for a future full randomized controlled trial (RCT) evaluating the use of low-gain amplification for bothersome tinnitus in patients with normal hearing. A pilot sample of 20 Veterans with normal hearing thresholds and bothersome tinnitus will be fit with mild amplification through receiver-in-the-canal hearing aids. Hearing aids will be programmed to provide a low-level of amplification, using NAL-NL2 guidelines for target gain. Outcome measures will be evaluated pre-fit and post-fit at two follow-up time points (2 weeks and 3 months post-fit). Outcomes will include the Tinnitus Functional Index (TFI), Hearing Handicap Inventory for Adults (HHIA) and the Quick Speech in Noise (QuickSIN) test. Outcomes pre and post hearing aid fit will be compared to evaluate whether the hearing aids provided benefit to participants in terms of their tinnitus and hearing outcomes. Additionally, participants will be interviewed at their last visit to find out their self-reported benefit from the hearing aids, as well as any barriers they encountered to wearing the hearing aids. Additionally, a group of VA clinical audiologists will be interviewed by telephone. These clinicians will be identified via an email survey sent to the VA audiologist email group, asking whether they are providing low-gain amplification for bothersome tinnitus to patients with normal hearing. The survey will also ask audiologists to volunteer if they are willing to participate in a brief telephone interview. The aim will be to identify at least ten audiologists who are fitting hearing aids in this way, and up to five who are not. These audiologists will be interviewed over the telephone to find out why they have incorporated this into their clinical practice (or why they have not), and inquire about specific fitting procedures and criteria for identifying candidates that they have used. These responses will inform the protocol of the future RCT. At the conclusion of this project, enough information will be collected to propose a controlled study of low-gain amplification for bothersome tinnitus in people with normal hearing. The protocol for that project will be informed by both the successful aspects of the pilot protocol as well as the input from VA clinicians who are doing this in the field. A preliminary evaluation of benefit provided by these hearing aids will provide justification for a large controlled study. Finally, the pilot data will provide the basis for a power calculation to determine sample size, as well as an estimate of drop-out rate to sufficiently adjust for attrition. A full RCT demonstrating efficacy of low-gain amplification for bothersome tinnitus in people with normal hearing would provide needed evidence supporting a clinical practice that has already gained some traction both within and outside VA. Robust research evidence is needed to support the continuation and future expansion of this practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Hearing Aids, Normal Hearing
Keywords
tinnitus, hearing aids, normal hearing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aid Study
Arm Type
Experimental
Arm Description
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.
Arm Title
VA Clinician Interviews
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Receiver in the canal (RIC) hearing aids
Intervention Description
The RIC hearing aids fitted to subjects in arm 1 of the study will be manufactured by Widex.
Primary Outcome Measure Information:
Title
Tinnitus Functional Index Change
Description
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.
Time Frame
The Tinnitus Functional index will be administered at baseline, 2-3 weeks after baseline, and 3 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for the Hearing Aid study include: 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). Inclusion criteria for the VA Clinician Interviews: -simply VA audiologists willing to participate. Exclusion Criteria: Exclusion criteria for the Hearing Aid study include: 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. Exclusion criteria for the VA Clinician Interviews are: not an audiologist not a VA employee.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Zaugg, AuD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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