Cochlear Implantaton for siNGLE-sided seafness
- Conditions
- single sided deafnessunilateral sensorineural hearing loss10022396
- Registration Number
- NL-OMON44754
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
- Age 18 or older.
- Acute onset of postlingual SSD, defined as onset unilateral hearing loss between >=3 months and <=10 years before time of inclusion.
- Hearing measurements:
> Pure Tone Audiometry of the deaf ear, defined as thresholds of 70 dB or higher on frequencies 0,5 - 4.0 kHz (average).
> Normal hearing on the contralateral ear, defined as pure tone audiometry thresholds of 30 dB or less on frequencies 0.5 - 4.0 kHz (average).
> Air bone gap 10 dB or smaller.
- Normal function of middle ear (i.e. no acute middle ear infections or tympanic membrane perforations).
- Dutch language proficiency.
- Willingness and ability to participate in all scheduled procedures outlined in the protocol.
- General health allowing general anaesthesia for the potential surgical implantation of a CI or BAHA.
- Patients covered by the Dutch health insurance.
- Patients should agree to be implanted with a CI or BAHA.
- Informed consent understood, filled out and signed by patient.
- Patients are not allowed to participate in another ongoing research study related to SSD or cochlear implantation
- previous experience with implanted BAHA or CI
- retrocochlear pathology
- abnormal cochlear anatomy in one or both ears (i.e. ossification)
- disability which could interfere with the completion of the tests (i.e. psychiatric problems or severe comorbidity with an expected survival of less than five years)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Performance on USTARR speech in noise test (see C1)</p><br>
- Secondary Outcome Measures
Name Time Method