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

Primary Purpose

Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
U8
N8 sound processor
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cochlear MelbourneRecruiting
  • Cochlear MacquarieRecruiting
  • HEARnet Clinical StudiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

U8 then N8

N8 then U8

Arm Description

Participants in this arm receive U8 followed by N8

Participants in this arm receive N8 followed by U8

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
October 2, 2023
Sponsor
Cochlear
Collaborators
Avania
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1. Study Identification

Unique Protocol Identification Number
NCT05866770
Brief Title
A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
Avania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
U8 then N8
Arm Type
Other
Arm Description
Participants in this arm receive U8 followed by N8
Arm Title
N8 then U8
Arm Type
Other
Arm Description
Participants in this arm receive N8 followed by U8
Intervention Type
Device
Intervention Name(s)
U8
Intervention Description
The U8 Research System
Intervention Type
Device
Intervention Name(s)
N8 sound processor
Intervention Description
Nucleus 8 sound processor
Primary Outcome Measure Information:
Title
Percent correct monosyllabic word scores.
Description
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.
Time Frame
3 months
Title
Adaptive sentence in noise scores (AuSTIN)
Description
To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Komal Arora
Phone
+61 432 218 588
Email
karora@cochlear.com
Facility Information:
Facility Name
Cochlear Melbourne
City
Melbourne E.
State/Province
Melbourne
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth English, postgraduate
Phone
+61386623105
Email
renglish@cochlear.com
Facility Name
Cochlear Macquarie
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2113
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esti Nel
Phone
+61448495008
Email
enel@cochlear.com
Facility Name
HEARnet Clinical Studies
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karyn Galvin, Phd
Phone
+61 407 052 505
Email
kgalvin@unimelb.edu.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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