NL-OMON34163
Completed
Phase 2
Cochlear*s Direct Acoustic Cochlear Stimulator Investigational Device (C-DACS ID) clinical trial CAG5229 - C-DACS clinical trial CAG5229
Cochlear AG0 sites5 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- fixation of the stapes
- Sponsor
- Cochlear AG
- Enrollment
- 5
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
Electroacoustic Stimulation of Extracochlear Cochlea-Implant ElectrodesH83Other diseases of inner earDRKS00030994niversitätsspital Zürich30
Recruiting
Not Applicable
Effective Stimulus to the Cochlea: Intra-Cochlear Pressure MeasurementH83.9H74.9Disease of inner ear, unspecifiedDisorder of middle ear and mastoid, unspecifiedDRKS00007665niversitätsSpital ZürichKlinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie25
Recruiting
Phase 1
Extracochlear electroacoustic stimulatioH83Other diseases of inner earDRKS00023375niversitätsSpital Zürich30
Completed
Not Applicable
Electric and acoustic stimulation (EAS) type cochlea implantation surgery (2)Bilateral profound sensorineural hearing lossJPRN-UMIN000005894Shinshu University Hospital10
Completed
Not Applicable
Electric and acoustic stimulation (EAS) type cochlea implantation surgeryBilateral profound sensorineural hearing lossJPRN-UMIN000002778Shinshu University Hospital24