A pre-market, open-label, within-subject, interventional study examining acceptability in actual-use scenarios of CP1110 Sound Processor, CP1175 Sound Processor and associated system components in experienced adult CI1000 Series cochlear implant recipients.

Cochlear Ltd0 个研究点目标入组 20 人开始时间: 2024年2月1日最近更新: 2024年6月10日

试验速览

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•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

•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)

发起方