None listed
Conditions
Brief summary
This is a pre-market, prospective, single-site, open-label, within-subject, non-randomised interventional study of acceptance of the CP1175 and CP1110 Sound Processors through use with adult cochlear implant recipients in real world scenarios. The investigational medical devices include an off-the-ear sound processor, a behind-the-ear sound processor, used in conjunction with investigational versions of fitting software, the Nucleus Smart App and a software measuring postoperative implant function. The objectives of the investigation are to collect device and procedure-related deficiencies to optimise clinical care for recipients of the investigational CI1000 Series cochlear implants.
Interventions
The investigational medical devices include the CP1175 sound processor and the CP1110 sound processor used in conjunction with an investigational version of Custom Sound Pro fitting software, the Nucleus Smart App and a software measuring postoperative implant function.
At study visits, subjects will participate in procedures which closely follow routine audiological care and management. During 2 planned visits, and up to 6 additional ad hoc visits, experienced audiologists will program each o
The investigational medical devices include the CP1175 sound processor and the CP1110 sound processor used in conjunction with an investigational version of Custom Sound Pro fitting software, the Nucleus Smart App and a software measuring postoperative implant function. At study visits, subjects will participate in procedures which closely follow routine audiological care and management. During 2 planned visits, and up to 6 additional ad hoc visits, experienced audiologists will program each of the investigational sound processors for subjects to trial in the clinic, including engaging in live conversations with investigator(s). Additionally, there will be a minimum of 2 take-home periods requiring subjects to use the off-the-ear (CP1175) and the behind-the-ear sound processors (CP1110) during their preferred waking hours and provide their subjective feedback on sound quality, comfort and ease of use. Visits are anticipated to be up to 2 hours in duration. Visits 1 and 2 will be a minimum of 2 weeks apart, and subsequent ad hoc visits are likely to occur monthly within the 12-month study duration.
Sponsors
Cochlear Ltd
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 at least one CI1032. 4. At least 2 months experience with a cochlear hearing implant. 5. Willingness to participate in and to comply with all requirements of the protocol. 6. Fluent speaker in English as determined by the investigator. 7. Willing and able to provide written informed consent
Exclusion criteria
1. Additional disabilities that would prevent participation in evaluations. 2. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 3. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 4. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation, as determined by the Investigator. 5. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation)
Outcome results
None listed