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Clinical Trials/NL-OMON23880
NL-OMON23880
Recruiting
N/A

Tinnitus and cochlear implantation

Department of Otorhinolaryngology and Head & Neck Surgery University Medical Center Utrecht, Utrecht, The Netherlands0 sites50 target enrollmentTBD
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Conditionstinnitus, bilateral hearing loss, bilateraal gehoorverlies

Overview

Phase
N/A
Intervention
Not specified
Conditions
tinnitus, bilateral hearing loss, bilateraal gehoorverlies
Sponsor
Department of Otorhinolaryngology and Head & Neck Surgery University Medical Center Utrecht, Utrecht, The Netherlands
Enrollment
50
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Department of Otorhinolaryngology and Head & Neck Surgery University Medical Center Utrecht, Utrecht, The Netherlands

Eligibility Criteria

Inclusion Criteria

  • •Patients aged 18 or older
  • •\- Seeking help for tinnitus
  • •\- Subjective tinnitus
  • •\- Tinnitus Functional Index (TFI) \> 32
  • •\- Tinnitus duration \> 1 and tinnitus stability \> 6 months
  • •\- Hearing level (measured with a maximum of 3 months before eligibility assessment):
  • •\> Audiometry (Pure Tone Average (PTA) at 0\.5,1,2,4 kHz): bilateral threshold between 50 and \< 75 dB
  • •\> Hearing threshold stability (PTA \< 5 dB change for 1 year in each ear)
  • •\- Becks Depression Inventory (BDI) \<19
  • •\- Health status allows general anesthesia and surgery for the cochlear implantation

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 1 year before start of the study
  • •\- 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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