HATSI-MB: A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
Study Details
Study Description
Brief Summary
A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The Research System is comprised of several components: the processing unit, fitting software and accessories. The sound processor converts sounds into electrical signals, which it sends, via a coil, to an implant to provide hearing sensation. The application of hearing aid technologies to Cochlear Implant recipients may provide benefit through matching the signal processing technologies across ears for bimodal listeners, enhance performance for CI-alone listening, and potentially lead to efficiency in algorithm development.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A (Adult Cochlear Implant recipients) Tha population for this arm is unilateral CI users, with eligibility of subjects supported by clinical records that confirm word score performance with Nucleus 8 sound processor in the CI ear is at least 10% greater than or equal 10% that of the word score in the contralateral ear when aided. |
Device: U8 Research system
The U8 Research System is comprised of the U8 Sound Processor, AlgoLab Test programming software and the Storage Layout Logger utility. The sound processor converts sounds into electrical signals, which it sends, via a coil, to an implant to provide hearing sensation.
|
Outcome Measures
Primary Outcome Measures
- Percent correct monosyllabic word scores. [3 months]
To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for monosyllabic words in quiet CNC words at 60 dB SPL (sound pressure level) Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
- Adaptive sentence in noise scores (AuSTIN) [3 months]
To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Eighteen years of age or older
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User of CI600, CI500 or CI24RE implant
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At least 3 months experience with a TGA approved Nucleus cochlear implant in at least one ear
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Fluent speaker of English
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A word speech recognition score of 20% or more when using the cochlear implant alone
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Willingness to participate in and to comply with all requirements of the protocol
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Willing and able to provide written informed consent
Exclusion criteria:
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Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
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Investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling
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Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cochlear Melbourne | Melbourne E. | Melbourne | Australia | 3002 |
| 2 | Cochlear Macquarie | Sydney | New South Wales | Australia | 2113 |
| 3 | HEARnet Clinical Studies | Carlton | Victoria | Australia | 3053 |
Sponsors and Collaborators
- Cochlear
- Avania
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AI5837