None listed
Conditions
Brief summary
The purpose of the pivotal study is to assess the user acceptance and speech perception with the Nucleus 7 Series Sound Processors but used by adult Cochlear Implant recipients. The study will characterise the speech perception difference for sentences in noise using Australian Speech Test in Noise with BKB target sentences and words in quiet using consonant-nucleus-consontant (CNC) Words for Nucleus 7 Series Sound Processor variants and commercially available sound processors (CP802 and CP910/920).
Interventions
The Nucleus 7 Series comprises of three external behind-the-ear worn processors (CP1000, CP1001, CP1002). The CP1000 sound processor is commercially available but will be loaded with investigational firmware for this study. Speech perception performance testing will be performed using these and comparator sound processors. All speech perception tests will be conducted in sound booths at the site. As subjects are existing Cochlear Implant recipients, explicit training or instructions will not be
The Nucleus 7 Series comprises of three external behind-the-ear worn processors (CP1000, CP1001, CP1002). The CP1000 sound processor is commercially available but will be loaded with investigational firmware for this study. Speech perception performance testing will be performed using these and comparator sound processors. All speech perception tests will be conducted in sound booths at the site. As subjects are existing Cochlear Implant recipients, explicit training or instructions will not be required. Practice runs for speech testing will be performed for participants to familiarise themselves with the testing procedures. Participants will be asked to listen to specific volumes with and without background noise. Participants will not leave the site with the CP1001, CP1002 or comparator sound processors. Participants will be asked to use the investigational processors for speech testing during 2 visits at the site, with each visit expected to be approximately 1.5-2 hours in duration. Participants test all devices on both visits. Investigational firmware will be loaded on to their own CP1000 processor for take home use. This sound processor is commercially available, however, participants to report any feedback or issues while using the investigational firmware. The investigational firmware does not impact sound quality and is not expected to impact their daily activities and will be removed at their final visit by reverting to commercially available firmware. All study related procedures will be performed by qualified research audiologists. There are no strategies needed to monitor adherence to the intervention as the research audiologist will conduct all speech performance testing with each participant. Data analytics can be accessed in Custom Sound Pro software should the investigator wish to note how many hours the investigational firmware was used during participants at-home use. Visits 1 and 2 will be at least 1 week apart. All participants will test all investigational devices and comparators during in-booth speech perception testing. To control for order effects, counterbalancing of the test order will be implemented for the primary and secondary speech perception endpoints. All permutations will be represented evenly across the subjects where possible. The same group of participants will be asked to test the comparator devices.
Sponsors
Cochlear Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
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 (CI512, CI532, CI522), Freedom Series (CI24RE(CA), CI24RE(ST), CI422), or N24 Series (CI24R(ST), CI24R(CS), CI24R(CA), CI24M) in at least one ear 4) At least 6 months experience with a cochlear implant. 5) At least 3 months experience with a Nucleus 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or Nucleus 7 (CP1000) Sound Processor 6) Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test 7) Willingness to participate in and to comply with all requirements of the protocol. 8) Fluent speaker in English as determined by the investigator 9) 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 the possible benefits, risks and limitations that are inherent to the procedures. 3) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 4) Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 5) Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 6) Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Outcome results
None listed