TinnitusNCT03904264
Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus
A study testing Receiver in the canal (RIC) hearing aids in people with Tinnitus and Hearing Aids, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Hearing Aids, Normal Hearing
- What is being tested?
- Receiver in the canal (RIC) hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Tinnitus, Hearing Aids, Normal Hearing
- Being tested
- Receiver in the canal (RIC) hearing aids
- Keywords
- tinnitus, hearing aids, normal hearing
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiver in the canal (RIC) hearing aidsDevice
The RIC hearing aids fitted to subjects in arm 1 of the study will be manufactured by Widex.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The Tinnitus Functional index will be administered at baseline, 2-3 weeks after baseline, and 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start24 Feb 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tara Zaugg, AuD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904264
- Sponsor's protocol ID
- C3196-P
- Status last verified
- Nov 2023
- First submitted
- 3 Apr 2019
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus
- ClinicalTrials.gov ID
- NCT03904264
- Acronym / sponsor ID
- C3196-P
- Conditions
- Tinnitus, Hearing Aids, Normal Hearing
- Keywords
- tinnitus, hearing aids, normal hearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid Study | Experimental | Device: Receiver in the canal (RIC) hearing aidsMeasure 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receiver in the canal (RIC) hearing aidsThe RIC hearing aids fitted to subjects in arm 1 of the study will be manufactured by Widex. | Device | Hearing Aid Study |
Primary outcome
Tinnitus Functional Index Change
Time frame: The Tinnitus Functional index will be administered at baseline, 2-3 weeks after baseline, and 3 months after baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara Zaugg, AuD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receiver in the canal (RIC) hearing aids in people with Tinnitus and Hearing Aids, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Functional Index Change (time frame: The Tinnitus Functional index will be administered at baseline, 2-3 weeks after baseline, and 3 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.