single sided deafness unilateral sensorineural hearing loss
Conditions
Interventions
Cochlear Implantation versus BAHA or CROSS
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18 or older. - Acute onset of postlingual SSD, defined as onset unilateral hearing loss between >=3 months and 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
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance on USTARR speech in noise test (see C1) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Performance on the Standard Dutch phoneme test (NvA-list) - Speech intelligibility test with spatially separated sources - Crescent of sound test, for sound localization - Speech, Spatial and Qualities of hearing scale (SSQ); questionaire to objectify several domains of hearing - Health Utilities Index (HUI3): questionnaire for general quality of life - Glasgow Benefit Inventory (GBI); questionnaire for general quality of life after surgery - Abbreviated Profile of Hearing Aid Benefit (APHAB); questionnaire for quality of hearing on several subdomains - Time Trade Off (TTO); quality of life question - Visual Analogue Scale (VAS); questionnaire on quality of life and hearing - EuroQol5D; questionnaire on quality of life - Hospital Anxiety and Disorder Scale (HADS); questionnaire objectifying anxiety and depression - Tinnitus Handicap Inventory (THI): tinnitus questionnaire - Tinnitus Questionnaire (TQ): tinnitus questionnaire - Tinnitus Burden Questionnaire (TBQ); tinnitus questionnaire - Cost diary for cost utility analysis - CI-patients: vocoder and pitch match experiments | — |
Countries
Netherlands
Outcome results
None listed