A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients

Not Applicable

Recruiting

• Conditions: Hearing Loss
• Interventions: Device: U8; Device: N8 sound processor

• Registration Number: NCT05866770
• Lead Sponsor: Cochlear

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

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 Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-19
• Study Start: 2023-09-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
N8 then U8	U8	Participants in this arm receive N8 followed by U8
U8 then N8	U8	Participants in this arm receive U8 followed by N8
N8 then U8	N8 sound processor	Participants in this arm receive N8 followed by U8
U8 then N8	N8 sound processor	Participants in this arm receive U8 followed by N8

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (3)

HEARnet Clinical Studies; 🇦🇺 Carlton, Victoria, Australia

Cochlear Melbourne; 🇦🇺 Melbourne E., Melbourne, Australia

Cochlear Macquarie; 🇦🇺 Sydney, New South Wales, Australia