deafness severe to profound bilateral sensorineural hearing loss
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age >= 18 years; Severe to profound bilateral post-lingual sensorineural hearing loss defined as >= 70 dB nHL on pure-tone audiometry in the range of 500, 1000 and 2000 Hz; Willingness and ability to participate in all scheduled procedures outlined in the research protocol; General health allowing general anesthesia in an outpatient setting; Quick access to communication and transportation in case of any complications; Good understanding of the Dutch language.
Exclusion criteria
Exclusion criteria: Severe to profound pre-lingual sensorineural hearing loss; Severe to profound unilateral sensorineural hearing loss; Previous cochlear implantation; Aberrant (cochlear) anatomy on CT-scan or chronic ear infection; General health does not allow general anesthesia in an outpatient setting; Disability that could interfere with audiologic evaluation and/or questionnaire fulfillment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure is general quality of life measured by the Health Utility Index - Mark 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are disease-specific quality of life, complications and cost-effectiveness. | — |
Countries
Netherlands