fixation of the stapes Otosclerosis
Conditions
Interventions
A regular stapedotomy will be performed in combination with a mastoidectomy, a
posterior tympanotomy and the placement of the experimental C-DACS ID device.
Sponsors
Cochlear AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Eighteen years of age or older 2. Mixed severe to profound hearing loss 3. Conductive hearing loss is a result of otosclerosis or prior failed stapes surgery 4. Bone conduction thresholds are worse than 40 dB HL on at least 3 out of 5 frequencies (500 Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz) but must be measurable at all five frequencies 5. Bone conduction thresholds equal to or greater than 30 dB HL in all frequencies 6. Air-bone gap equal to or greater than 30 dB HL on at least 3 out of 5 frequencies 7. Bone conduction of contra-lateral ear is equal to or worse than 30 dB HL at the best frequency
Exclusion criteria
Exclusion criteria: 1. Participation in another medical device study 2. Unwillingness or inability of the subject to comply with all study requirements 3. Bone conduction threshold exceeds 80 dB HL at 1 or more out of 5 frequencies (500 Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz) 4. Air conduction threshold exceeds 120 dB HL at 1 or more out of 5 frequencies (500 Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz) 5. Medical or psychological conditions that would contraindicate undergoing surgery 6. Sudden hearing loss 7. Disabling tinnitus 8. Insufficient mastoid and/or ear canal size (to be checked on CT scan) 9. Other criteria at investigator*s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Audiological: aided free field hearing thresholds and scores of speech discrimination. Chirurgisch: complication registration and bone conduction thresholds. The subjective experiences of the participants will be tested by the APHAB questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| nvt | — |
Countries
Netherlands
Outcome results
None listed