CTRI/2021/11/038186
Recruiting
未知
IMPLANTATION WITH MEDTECH COCHLEAR IMPLANT SYSTEM IN ADULTS
HCL TECHNOLOGIES LIMITED0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: H903- Sensorineural hearing loss, bilateral
- Sponsor
- HCL TECHNOLOGIES LIMITED
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.18 years of age or older
- •2\.Severe\-to\-profound, sensorineural hearing loss ( \>70 dB), determined by pure tune at 500Hz, 1000Hz and 2000Hz
- •3\.bilateral or Postlingual onset of severe or profound hearing loss
- •4\.Limited benefit from appropriate binaural hearing aids (verified by standard clinical practice), as defined by aided test scores of 50% correct or less in the ear to be implanted (60% or less in the best\-aided listening condition) on tests of open set sentence recognition.
- •I. Consistent with the Minimum Speech Test Battery (2011\), it is required that all subjects be evaluated
- •5\.Moderate to profound hearing loss in the low frequencies and profound (ââ?°Â¥ 90 dB HL) hearing loss in the mid to high speech frequencies
- •6\.eBERA ââ?¬â?? Electrical brainstem evoked response audiometry to ensure benefit from the Implant. eBERA can be performed during surgery itself.
Exclusion Criteria
- •1\.Sensorineural severe\-to\-profound hearing loss greater than 20 years at ââ?°Â¥ 2 kHz and above
- •2\.Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted
- •3\.Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery
- •4\.Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination
- •5\.Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway (audio Neuropathy Spectrum disorder).
- •6\.Active middle\-ear infection
- •7\.Tympanic membrane perforation
- •8\.Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
- •9\.Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak
- •10\.Patients with recurrent episodes of bacterial meningitis
Outcomes
Primary Outcomes
Not specified
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