NL-OMON54676
Recruiting
Not Applicable
Tinnitus implant: Tinnitus and cochlear implantation - Tinnitus and cochlear implantation
niversitair Medisch Centrum Utrecht0 sites50 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18 or older
- •Seeking help for tinnitus
- •Subjective tinnitus
- •Tinnitus Functional Index (TFI) \> 32
- •Tinnitus duration \> 1 year and subjective tinnitus stability \> 6 months
- •Hearing level:
- •o Audiometry (Pure Tone Average (PTA) at 0\.5,1,2 kHz): bilateral threshold \>\= 40
- •and \<\= 80 dB
- •o Hearing thresholds in the ear to be implanted (\>\= 4 kHz) \>\= 50 dB
- •o Hearing threshold stability (PTA \< 5 dB change for 1 year in each ear)
Exclusion Criteria
- •Patient primary seeking help for non\-tinnitus hearing problems
- •Abnormal cochlear anatomy(i.e. ossification)
- •Comorbidity with an expected survival of less than five years based on
- •medical history as assessed by clinician and in electronical patient file
- •Additional handicaps that would prevent participation in the evaluations
- •Presence of any instable psychiatric condition within 6 months before start
- •of the study
- •Patient with active clinical depression within the 6 months before start of
- •Unrealistic expectations on the part of the patient regarding the possible
- •benefits, risks and limitations that are inherent to the procedure
Outcomes
Primary Outcomes
Not specified
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