A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients (HATSI-MB)

Cochlear

Status: Enrolling

Conditions: Hearing Loss

Treatments: Device: N8 sound processor; Device: U8

Study type: Interventional

Funder types: Industry

Identifiers

NCT05866770

AI5837

Details and patient eligibility

About

A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eighteen years of age or older
• User of CI600, CI500 or CI24RE implant
• At least 3 months experience with a TGA approved Nucleus cochlear implant in at least one ear
• Fluent speaker of English
• A word speech recognition score of 20% or more when using the cochlear implant alone*
• Willing and able to provide written informed consent *This can be based on clinical data if collected within the last 12 months

Exclusion criteria

• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• Investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling
• Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

U8 then N8

Other group

Description:

Participants in this arm receive U8 followed by N8

Treatment:

Device: N8 sound processor

Device: U8

N8 then U8

Other group

Description:

Participants in this arm receive N8 followed by U8

Treatment:

Device: N8 sound processor

Device: U8