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

Hearing Loss Clinical Trial

— HATSI-MB  

Official title:

A Feasibility, Prospective, Multi-centre, Repeated Measures Investigation Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866770
• Other study ID #: AI5837
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2023
• Source: Cochlear
• Contact: Komal Arora
• Phone: +61 432 218 588
• Email: karora[@]cochlear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• U8
The U8 Research System
• N8 sound processor
Nucleus 8 sound processor

Locations

Country	Name	City	State
Australia	HEARnet Clinical Studies	Carlton	Victoria
Australia	Cochlear Melbourne	Melbourne E.	Melbourne
Australia	Cochlear Macquarie	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	Avania

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent correct monosyllabic word scores.	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.	3 months
Primary	Adaptive sentence in noise scores (AuSTIN)	To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.	3 months