Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.

Tinnitus Clinical Trial

Official title:

Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292534
• Other study ID #: SRF-481
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 20, 2023

Study information

• Verified date: October 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.

Description:

2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 20, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hearing loss
• candidate for hearing aid amplification
• Bothersome chronic tinnitus (3 months+)

Exclusion Criteria:

• age less than 18 years
• normal hearing
• tinnitus presence for less than 3 months
• tinnitus not bothersome enough to warrant intervention
• non hearing aid candidates

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Tinnitus

Intervention

Device:
• hearing aid amplification
Hearing aid will be fit to prescribed participant hearing loss.
• hearing aid amplification with an added sound
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.

Locations

Country	Name	City	State
United States	The State University of New York at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	The State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (2)

Henry JA, Griest S, Thielman E, McMillan G, Kaelin C, Carlson KF. Tinnitus Functional Index: Development, validation, outcomes research, and clinical application. Hear Res. 2016 Apr;334:58-64. doi: 10.1016/j.heares.2015.06.004. Epub 2015 Jun 12. — View Citation

Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0. Erratum In: Ear Hear. 2012 May;33(3):443. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Functional Index evaluation (TFI)	Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.	TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each. Up to 1 year of study completion, a follow-up TFI will be done for comparison reasons.