NCT07298499

Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus

Post-Market Clinical Follow-Up of Hearing Aids and Tinnitus Masker Technology

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Starkey Laboratories, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a Post-Market Clinical Investigation whose primary purpose is to evaluate hearing aid amplification and tinnitus masker performance for individuals with hearing loss and tinnitus. There are two primary hypotheses that will be assessed in this study: The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. The use of well-fit amplification in conjunction with a tinnitus masker improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. Participants will be fit with hearing aids for 6 months and a tinnitus masker will be activated at the 3-month mark of the study. Outcome measures will evaluate device performance and participant benefit from the devices throughout the study duration.

Detailed description

The purpose of this study is to evaluate hearing aid amplification and tinnitus masker performance, and clinical benefit for adults with hearing loss and tinnitus. The participants of the study will include approximately 100 adults with bilateral hearing loss ranging from mild to profound and mild to severe tinnitus as determined by the Tinnitus Handicap Inventory. Participants will be fit with hearing aids by a licensed research audiologist. Hearing aid fittings will be verified using real-ear measurements and performance will be evaluated by the response accuracy compared to hearing aid prescriptive targets. Participants will first be fit with only amplification for 3 months. The participants will wear the hearing aids regularly in the field and return to the research facility at several intervals to complete measures of hearing aid performance and listening tasks. At the three-month mark, a tinnitus masker will be turned on through the participant's hearing aids. The masker will be adjusted to participant preferences for sound quality and masker output will be captured using real-ear measurements. The participants will then wear the hearing aids with a tinnitus masker enabled for 3 months and return to the research facility at several intervals to complete measures of hearing aid performance and listening perception tasks. Through this study the following hypotheses will be tested: The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. The use of well-fit amplification in conjunction with an ear-level tinnitus masker improves participants' ability to hear and improves tinnitus symptoms. According to the American Speech, Language, and Hearing Association, "fitting and monitoring the use of tinnitus maskers, hearing aids, or other ear-level sound generators" are all acceptable management techniques for tinnitus. However, there is not guidance on the order of management strategies. In the ASHA guidance and peer-reviewed literature, there is no evidence of patient characteristics that indicate the patient will benefit from one intervention over another. There is previous research that indicates well- fit hearing aids providing amplification alone improves tinnitus symptoms in individuals with hearing loss and tinnitus. Widely accepted tinnitus management programs -- Tinnitus Retraining Therapy, Progressive Tinnitus Management, and Tinnitus Activities Treatment-- recommend the use of tinnitus masking devices in addition to amplification as a component of tinnitus management for individuals with hearing loss and tinnitus . In randomized controlled studies, it has been found that participants with tinnitus showed equal improvement with tinnitus symptoms when fit with amplification only and when fit with amplification and sound masker devices when compared to no intervention. These studies indicate improvement in tinnitus with intervention versus no intervention. The present study will continue this line of research with participants wearing hearing aids with amplification alone and hearing aids with amplification and a tinnitus masker. For this study, all participants will first be fit with hearing aids providing amplification only for 3 months and then the tinnitus masker will be enabled in the hearing aids for the second half of the study. This study design was chosen due to the inability to blind the participant or researcher from the intervention and because it mimics many patients' experiences with clinical protocols. The study design also reduces the potential ethical concern of providing the tinnitus masker and removing it as the researchers may be withholding an effective tinnitus management tool after the participant has already grown accustomed to it. When the tinnitus masker is enabled at the 3-month mark, the participants will continue to have access to an amplification only program they can navigate to with their hearing aids. The participants will be encouraged to remain in the tinnitus masker program as much as possible. The study hypotheses will be tested by comparing clinical benefit questionnaires against normative data or quantifying minimal clinically important differences from unaided to aided conditions for individual participants. Performance of amplification and tinnitus maskers will be verified using real-ear measurements and will confirm the safety of the hearing aids and tinnitus maskers by following the participants for 6 months.

Conditions

• Hearing Aid
• Tinnitus

Interventions

Type	Name	Description
DEVICE	Hearing Aid	Inclusion of hearing aid or not for listening
DEVICE	Tinnitus Masker	Inclusion of tinnitus masker in device

Timeline

• Start date: 2025-07-07
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-12-23
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study