deafness severe-to-profound hearing loss
Conditions
Interventions
None listed
Sponsors
Advanced Bionics Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * * 18 years of age * Postlingual onset of severe-to-profound hearing loss (* 4 years of age) * Sensorineural hearing loss of severe or greater degree in both ears, defined as a pure-tone average (PTA: 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz) of * 70 dB HL * Marginal hearing aid benefit with appropriately fitted hearing aids, defined as a monosyllabic word score in quiet of * 50% in the best-aided condition * Proficient in the local language of the investigational center * Willingness to participate in all scheduled procedures outlined in the protocol
Exclusion criteria
Exclusion criteria: * Cochlear malformation or obstruction that would preclude adequate insertion of electrode array * Presence of additional disabilities that would prevent or interfere with participation in the required study procedures * Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or to participate in the study related procedures * Evidence of central auditory lesion or compromised auditory nerve * Pregnancy at time of surgery (responsibility of the hospital)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Section 2.2 van het CIP | — |
Secondary
| Measure | Time frame |
|---|---|
| Section 2.2 van het CIP | — |
Countries
Netherlands
Outcome results
None listed