Performance barriers for cochlear implant recipients
- Conditions
- auditory sensitivitycochlear implantEar - Deafness
- Registration Number
- ACTRN12620001300965
- Lead Sponsor
- Cochlear Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
1. Minimum duration of cochlear implant experience of 12 months in the ear to be assessed
2. Implanted greater than or equal to 2007 in the ear to be assessed in the study.
3. Word recognition score in quiet at a conversational level that is either a) below the 35th percentile (poorer”) or b) above the 65th percentile of the site’s implanted population (implanted greater than or equal to 2007) at the site AND greater than or equal to 10% higher than the pre-operative aided word score in the ear to be assessed in the study (good”).
4. Pre-operative word score in the implanted ear to be assessed in the study less than or equal to 80%
5. 18 years of age or older at the time of implantation of the ear to be assessed in the study.
6. Appropriate pre- and post-operative imaging; specifically, pre-operative MRI, pre-operative CT and post-operative CT that allows sufficient resolution to identify individual electrode contacts.
7. Willingness to participate in and to comply with all requirements of the protocol.
1) Limited conditioning of the auditory pathway. Specifically, recipients to be excluded are those who were diagnosed with prelingual severe to profound hearing loss at less than or equal to 2 years of age AND meet at least one of the following criteria
i. Use non-speech based means as a primary mode of communication (for example, sign language)
ii. Have an aided post operative word score in quiet at 65 dB SPL in the implanted ear that is less than 5%
2) Diagnosed cognitive deficit deemed by the investigators to potentially impact outcomes
3) Restricted electrical frequency allocation table due to current use of combined electric-acoustic stimulation (either with or without amplification in the ear to be assessed)
4) Non-fluent in the language used for assessments at the investigational site
5) Additional handicaps that would prevent participation in evaluations
6) Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigation
7) Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
8) Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
9) Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post-implantation outcome measures of auditory sensitivity, aided thresholds at 250, 500, 750, 1000, 1500, 2000, 3000, 4000 and 6000Hz in Visit 1.[Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).];Post-implantation outcome measures of auditory sensitivity, phoneme discrimination in noise (LIT) and in quiet (PDQ) in Visit 2.[Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).];Post-implantation outcome measures of auditory sensitivity, Quick Spectral Modulation Detection (QSMD) test in Visit 2.[Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).]
- Secondary Outcome Measures
Name Time Method