single-sided deafness, unilateral hearing loss, single-sided hearing loss, unilateral deafness, eenzijdige doofheid, unilaterale doofheid, eenzijdig gehoorverlies, unilateraal gehoorverlies
Conditions
Interventions
Randomised:
Cochlear Implantation (CI) versus Bone Conduction Device (BCD) or Contralateral Routing of Sound system (CROS)
Sponsors
Department of Otorhinolaryngology and Head & Neck Surgery University Medical Center Utrecht, Utrecht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: - 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 BCD. - Patients covered by the Dutch health insurance. - Patients should agree to be implanted with a CI or BCD. - 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 BCD 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 the modified Plomp hearing test. | — |
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) - Health Utilities Index (HUI3) - Glasgow Benefit Inventory (GBI) - Abbreviated Profile of Hearing Aid Benefit (APHAB) - Time Trade Off (TTO) - Visual Analogue Scale (VAS) - EuroQol5D - Hospital Anxiety and Disorder Scale (HADS) - Tinnitus Handicap Inventory (THI) - Tinnitus Questionnaire (TQ) - Tinnitus Burden Questionnaire (TBQ) - Cost diary for cost utility analysis | — |
Contacts
Public ContactH.P.M. Peters
Department of Otorhinolaryngology and Head & Neck Surgery, University Medical Center Utrecht, Huispost G05.129, Heidelberglaan 100
Outcome results
None listed