Tinnitus, Hearing Loss, Cochlear Implant Users
Conditions
Keywords
Sound therapy, Tinnitus relief
Brief summary
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.
Interventions
DEVICECART sound therapy
The study consists of two parts: Phase 1: laboratory evaluation of CART sound acceptability Phase 2: take home evaluation of CART sound therapy including baseline without CART
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS) | week 0 | Visual Analogue Scale (VAS) score on tinnitus |
| Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI) | week 0 | — |
Countries
Netherlands
Outcome results
None listed