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

Sonova

Status: Completed

Conditions: Tinnitus; Hearing Loss, Sensorineural

Treatments: Device: hearing aid amplification; Device: hearing aid amplification with an added sound

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05292534

SRF-481

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

Amplification-only

Active Comparator group

Description:

Hearing aid will be fit to prescribed participant hearing loss.

Treatment:

Device: hearing aid amplification

Amplification with added sound

Active Comparator group

Description:

Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.

Treatment:

Device: hearing aid amplification with an added sound

No intervention

No Intervention group

Description:

Participants will return to their original unaided state.