Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing Loss
- Sponsor
- Cochlear
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Report on Degree of Hearing as Measured by Pure Tone Audiogram
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Meet current cochlear implant indications at the implanting centre
- •In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 \& 500Hz in the ear to be implanted.
- •Fluent speaker in the local language used to assess clinical performance
- •Eighteen years of age or older at the time of implantation with no upper age limit
Exclusion Criteria
- •Evidence of hearing loss prior to 5 years of age.
- •Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
- •Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
- •Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
- •Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
- •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.
- •Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.
- •Active middle-ear infection,
- •Tympanic membrane perforation
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
Outcomes
Primary Outcomes
Report on Degree of Hearing as Measured by Pure Tone Audiogram
Time Frame: 6 months and 12 months post activation
unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Report on Clinical Performance in Quiet and Noise
Time Frame: 3 months, 6 months and 12 months post activation
Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
Report of Medical/Surgical and Device Related Adverse Events.
Time Frame: 12 months post activation.
Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.
Secondary Outcomes
- Glasgow Benefit Inventory (GBI).(6 months post activation)
- Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)(Preoperative and 6 months post activation)