Hearing Aids + Tinnitus Masker for Tinnitus

(StarkeyPMCF Trial)

Overseen By Maddie Olson, AuD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Starkey Laboratories, Inc

Disqualifiers: Ear deformity, Ear discharge, Dizziness, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if hearing aids, with or without an added tinnitus masker (a device that produces sound to help mask ringing), can improve hearing and reduce tinnitus. Participants will use hearing aids for six months; after three months, a tinnitus masker will be added to assess any additional relief. The trial seeks individuals with hearing loss in both ears, mild to severe tinnitus, and the ability to travel to the research site. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options for tinnitus.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the study team or your doctor for guidance.

What prior data suggests that these devices are safe for individuals with hearing loss and tinnitus?

Research has shown that hearing aids, whether used alone or with a tinnitus masker, are generally easy for people to use. One study found that 51% of people with tinnitus noticed less ringing in their ears after using hearing aids. This suggests that hearing aids can help with both hearing and reducing the irritation of tinnitus.

Tinnitus maskers are devices that create noise to cover up the ringing in the ears. They are safe to use and often form part of tinnitus retraining therapy. These devices work by matching the sound of the ringing to help hide it.

Overall, both hearing aids and tinnitus maskers are safe, with studies reporting no major side effects. People usually find them helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for tinnitus, which typically involves using hearing aids or sound therapy separately, this treatment combines these approaches into one. Researchers are excited because it integrates a hearing aid with a tinnitus masker, potentially enhancing sound amplification while simultaneously masking the tinnitus sounds. This dual-action approach could provide a more comprehensive management of symptoms, offering relief to individuals who haven't found success with traditional methods.

What evidence suggests that hearing aids and tinnitus maskers are effective for tinnitus?

Studies have shown that hearing aids can reduce the effects of tinnitus, a ringing in the ears, and improve hearing. Research indicates that hearing aids, especially those with built-in sound generators, lessen the distress caused by tinnitus and enhance daily life. In this trial, participants may receive either amplification alone or amplification plus a tinnitus masker. Sound therapy with tinnitus maskers has effectively reduced tinnitus discomfort and increased patient satisfaction. Combining hearing aids with sound therapy may enhance these benefits. Overall, both treatments show promise in making tinnitus easier to manage and improving hearing. ^{6 7 8 9 10}

Who Is on the Research Team?

Michelle Hicks, Ph.D.

Principal Investigator

VP Education and Audiology

Are You a Good Fit for This Trial?

This trial is for adults with hearing loss and tinnitus. Participants will use a hearing aid, and after three months, a tinnitus masker will be added. They should not have used similar devices before the study.

Inclusion Criteria

Native English speaking (defined that all education was done in English)

I have hearing loss in both ears.

I experience ringing in my ears.

Exclusion Criteria

Participants will be advised to consult promptly a doctor, preferably an ear specialist such as an ENT, prior to being fit with the study devices, if they display any of the following conditions:

I often have excessive ear wax or think there might be something in my ear canal.

Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Fitting and Amplification

Participants are fit with hearing aids providing amplification only for 3 months

12 weeks

Session 1 (day 1), Session 2 (2 weeks), Session 3 (6 weeks), Session 4 (12 weeks)

Amplification with Tinnitus Masker

Tinnitus masker is enabled in the hearing aids for the second half of the study

12 weeks

Session 5 (14 weeks), Session 6 (18 weeks), Session 7 (24 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hearing Aid
• Tinnitus Masker

Trial Overview

The study tests if using a hearing aid alone or in combination with a tinnitus masker can improve hearing and lessen tinnitus symptoms compared to no treatment at all over six months.

How Is the Trial Designed?

Group I: Amplification with or without masker Experimental Treatment 2 Interventions

Amplification alone or amplification plus tinnitus masker

Who Is Running the Clinical Trial?

Starkey Laboratories, Inc

Lead Sponsor

Trials

4

Recruited

420+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38271299/

Efficacy of Amplification for Tinnitus Relief in People With ...

Purpose: The study aimed to evaluate the efficacy of amplification with hearing aids for people with chronic subjective tinnitus and mild ...

2.

pubs.asha.org

pubs.asha.org/doi/10.1044/2023_JSLHR-23-00031

Efficacy of Amplification for Tinnitus Relief in People With ...

The study aimed to evaluate the efficacy of amplification with hearing aids for people with chronic subjective tinnitus and mild hearing loss.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03716544

Efficacy of Amplification With Hearing Aids for Tinnitus Relief

Participants will be required to use the hearing aids for at least 2 hours daily for 12 months. Intervention/Treatment, Device : Amplification with hearing aid.

4.

frontiersin.org

frontiersin.org/journals/audiology-and-otology/articles/10.3389/fauot.2023.1238164/full

Hearing aids with tinnitus sound support reduce ...

Conclusions: The results confirm previous findings that hearing aids assist in reducing the impact of tinnitus on daily life. The Oticon ...

5.

mdpi.com

mdpi.com/2039-4349/14/4/57

The Important Role of Hearing Aids with Sound Generators

Hearing aids (HAs), especially those with sound generators (SGs), are used in the management of tinnitus.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07298499

Amplification and Tinnitus Masker Performance and Benefit ...

Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring ...

7.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK557026/

Evidence review for sound therapy and amplification devices

There was no clinical difference between combination hearing aids and hearing aids in terms of improving tinnitus severity. The overall quality of the evidence ...

8.

ncrar.research.va.gov

ncrar.research.va.gov/NCRAR/Publications/Documents/ValidationOfNovelCombHA-TinnitusDevice.pdf

Validation of a Novel Combination Hearing Aid and Tinnitus ...

Conclusions: Results of this study suggest that the use of hearing aids alone or hearing aids plus the use of sound generators both provide significant benefit ...

9.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/p010023b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Twenty-one of 41 (51%) subjects reporting tinnitus pre- implant reported that their hearing aid decreased their perception of tinnitus. • ...

10.

ecfr.gov

ecfr.gov/current/title-21/chapter-I/subchapter-H/part-874/subpart-D/section-874.3400

21 CFR 874.3400 -- Tinnitus masker.

A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises.