None listed
Conditions
Brief summary
The experimental sound processor and associated accessories is a sound processor that aims to combine the sound processing, connectivity, comfort and discretion of the behind-the-ear Nucleus 7 sound processor, This study requires usability listing tests in both the clinic and at-home use of the prototype design.
Interventions
All participants will be fitted with an investigational sound processor (CP1150) for use with 1 or 2 ears by a qualified audiologist. It will take approximately 30 minutes to fit a sound processor (connect to the existing cochlear implant).
The study will run over 3 phases for a total of 9 months. In phase 1, only one ear will be fitted. If the subject has 2 implants, the second will not be used. In phases 2 and 3, if the subject has two compatible implants, then both will be used.
Phase 1 i
All participants will be fitted with an investigational sound processor (CP1150) for use with 1 or 2 ears by a qualified audiologist. It will take approximately 30 minutes to fit a sound processor (connect to the existing cochlear implant). The study will run over 3 phases for a total of 9 months. In phase 1, only one ear will be fitted. If the subject has 2 implants, the second will not be used. In phases 2 and 3, if the subject has two compatible implants, then both will be used. Phase 1 is usability and speech testing conducted on a single day. Phase 2 includes a 2-4 week take-home period reviewing the usability of the CP1150. Phase 3 includes a 2-4 week take-home period reviewing the usability of the device and speech testing. There may be up to 4 months between phases; during this time you will not be using the CP1150 sound processor. Device use will be monitored through questionnaires, diaries, data logs from the sound processor and usability testing scenarios to be completed during periods of at-home use. A total of 5 clinical visits will be required over the 3 phases. Each clinic visit will take approximately 3 hours. Usability testing is reviewing a list of activities to determine if the subject can complete them. Speech testing is completed in a sound booth. All the procedures are conducted by an investigator who is a trained audiologist.
Sponsors
Cochlear Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older 2. Post lingually deafened 3. Implanted with the CI500 series or Freedom series in at least one ear 4. At least 3 months experience with a cochlear implant 5. Able to complete open set speech perception tests as determined by the investigator 6. Willingness to participate in and to comply with all requirements of the protocol 7. Fluent speaker in the language used to assess speech perception performance as determined by the investigator 8. Willing and able to provide written informed consent
Exclusion criteria
1. Additional disabilities that would prevent participation in evaluations 2. Unrealistic expectations on the part of the subject, regarding possible benefits, risks and limitation that are inherent to the procedures 3. Implant location that would result in undesirable hearing performance or discomfort, as determined by the investigator 4. Unable or unwilling to comply with the requirements of the clinical investigation, as determined by the investigator 5. Investigator site personnel directly affiliated with this this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling 6. Cochlear employees or employees of contract research organisations or contractors engaged by Cochlear for the purposes of this investigation 7. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device 8. Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator)
Outcome results
None listed