Sound Therapy for Tinnitus Relief in Cochlear Implant Users

Cochlear

Status: Terminated

Conditions: Tinnitus, Hearing Loss, Cochlear Implant Users

Treatments: Device: CART sound therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03026829

CEL5684

Details and patient eligibility

About

The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from Tinnitus (CART) firmware.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Self-reported tinnitus during standard Cochlear Implant (CI) activation for at least one month
• At least three months use of unilateral or bilateral Nucleus CI(s) driven by a CP900 Sound Processor. For bilateral use the most recently activated CI is used for at least three months
• Native speaker and fluency in the language used in the assessments (i.e. Dutch)

Exclusion criteria

• Additional handicaps that would prevent participation in evaluations
• History of psychiatric disorders or depression (on investigator's opinion)
• Unrealistic expectations as identified by the clinician on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
• Pulsatile or diagnosed objective / middle ear tinnitus

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

CART sound therapy

Experimental group

Treatment:

Device: CART sound therapy