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A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults. (SASC)

Primary Purpose

Hearing Impairment, Sensorineural

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Focused Multipolar Stimulation (FMS) strategy
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Impairment, Sensorineural

Eligibility Criteria

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

Inclusion Criteria: 1) Candidate for unilateral cochlear implantation according to bilateral sensorineural hearing loss criteria, who has decided to proceed with implantation through routine processes. a) Bilateral sensorineural hearing loss criteria for clinics in the United States: i) Ear to be implanted: Moderate to profound sensorineural hearing loss, defined as a pure-tone average (PTA) (250 - 1000 Hz) ≥ 40 dB HL and a PTA (2000 - 8000 Hz) ≥ 65 dB HL Aided word score ≤ 40% ii) Contralateral ear: (1) PTA (500, 1000, 2000, and 4000 Hz) > 30 dB HL (2) Aided word score ≤ 80% b) Bilateral sensorineural hearing loss criteria for clinics in Belgium: i) Both ears: PTA (500, 1000, 2000, and 4000 Hz) ≥ 70 dB HL for average of 3 out of 4 frequencies Unaided phoneme score ≤ 50% on CVC in quiet at 70 dB SPL in free field ABR peak ≥ 75 dB nHL 2) 18 years of age or older. 3) Fluent in the language used for speech testing. 4) Willing to comply with all investigational requirements. 5) Willing and able to provide written informed consent - Exclusion Criteria: Previous or existing cochlear-implant recipient. Severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age. Duration of severe to profound hearing loss > 20 years in the ear to be implanted. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array. Diagnosis of auditory neuropathy. Deafness due to lesions of the acoustic nerve or central auditory pathway. Pregnant at the time of surgery. Additional handicaps that would prevent or restrict participation in the audiological evaluations. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device. 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 Organisations or contractors engaged by Cochlear for the purposes of this investigation. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device

Sites / Locations

  • Rocky Mountain Ear CenterRecruiting
  • Denver Research and Technology Lab
  • Universitair Ziekenhuis LeuvenRecruiting
  • Cochlear Technology Centre Belgium
  • ENT Department, Sint-Augutinus AntwerpRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adult Cochlear implant

Arm Description

Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters

Outcomes

Primary Outcome Measures

Mean difference across maximum map stimulation (C) levels
Mean difference across maps using alternative modes and sound coding parameters for the highest and average comfortable loudness level (clinical unit) (C-level).
Mean difference across Spectral resolution (QSMD)
Mean difference across maps using alternative modes and sound coding parameters for spectral resolution (% correct) (QSMD - Quick spectral modulation detection)
Mean difference across phoneme discrimination (LIT- Language independent test)
Mean difference across maps using alternative modes and sound coding parameters for phoneme discrimination (% correct) (LIT - Language independent test)

Secondary Outcome Measures

Full Information

First Posted
November 9, 2022
Last Updated
July 11, 2023
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT05641155
Brief Title
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.
Acronym
SASC
Official Title
An Early Feasibility, Prospective, Exploratory Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding Enhancements in Adult Cochlear Implant Recipients (SASC).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this early feasibility study is to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP stimulation) in cochlear implant recipients. This study will iteratively evaluate different parameter sets that intend to maximize hearing performance benefits within technical requirements. This study is exploratory in nature and will achieve its objectives through ongoing review and adjustment of device parameters and fitting
Detailed Description
Alternative modes of stimulation will be investigated that may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical benefits over MP stimulation. The purpose of this study is to balance the clinical improvements of alternative modes of stimulation with technical and usability requirements for power usage. By iteratively evaluating different sets of stimulation and sound coding parameters, this study will determine device settings and fitting techniques. Measures of speech recognition, listening effort, neural responses, electrode placement, battery life, and usability acceptance will be obtained to evaluate clinical benefits

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adult Cochlear implant
Arm Type
Experimental
Arm Description
Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters
Intervention Type
Device
Intervention Name(s)
Focused Multipolar Stimulation (FMS) strategy
Intervention Description
Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters.
Primary Outcome Measure Information:
Title
Mean difference across maximum map stimulation (C) levels
Description
Mean difference across maps using alternative modes and sound coding parameters for the highest and average comfortable loudness level (clinical unit) (C-level).
Time Frame
10 weeks
Title
Mean difference across Spectral resolution (QSMD)
Description
Mean difference across maps using alternative modes and sound coding parameters for spectral resolution (% correct) (QSMD - Quick spectral modulation detection)
Time Frame
10 weeks
Title
Mean difference across phoneme discrimination (LIT- Language independent test)
Description
Mean difference across maps using alternative modes and sound coding parameters for phoneme discrimination (% correct) (LIT - Language independent test)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Candidate for unilateral cochlear implantation according to bilateral sensorineural hearing loss criteria, who has decided to proceed with implantation through routine processes. a) Bilateral sensorineural hearing loss criteria for clinics in the United States: i) Ear to be implanted: Moderate to profound sensorineural hearing loss, defined as a pure-tone average (PTA) (250 - 1000 Hz) ≥ 40 dB HL and a PTA (2000 - 8000 Hz) ≥ 65 dB HL Aided word score ≤ 40% ii) Contralateral ear: (1) PTA (500, 1000, 2000, and 4000 Hz) > 30 dB HL (2) Aided word score ≤ 80% b) Bilateral sensorineural hearing loss criteria for clinics in Belgium: i) Both ears: PTA (500, 1000, 2000, and 4000 Hz) ≥ 70 dB HL for average of 3 out of 4 frequencies Unaided phoneme score ≤ 50% on CVC in quiet at 70 dB SPL in free field ABR peak ≥ 75 dB nHL 2) 18 years of age or older. 3) Fluent in the language used for speech testing. 4) Willing to comply with all investigational requirements. 5) Willing and able to provide written informed consent - Exclusion Criteria: Previous or existing cochlear-implant recipient. Severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age. Duration of severe to profound hearing loss > 20 years in the ear to be implanted. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array. Diagnosis of auditory neuropathy. Deafness due to lesions of the acoustic nerve or central auditory pathway. Pregnant at the time of surgery. Additional handicaps that would prevent or restrict participation in the audiological evaluations. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device. 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 Organisations or contractors engaged by Cochlear for the purposes of this investigation. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Fung
Phone
3038807305
Email
afung@cochlear.com
First Name & Middle Initial & Last Name or Official Title & Degree
Naomi Croghan
Phone
303 790 9010
Email
ncroghan@cochlear.com
Facility Information:
Facility Name
Rocky Mountain Ear Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Fung
Phone
303-880-7305
Email
afung@cochlear.com
First Name & Middle Initial & Last Name & Degree
David Kelsall, MD
Facility Name
Denver Research and Technology Lab
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Fung
Phone
3038807305
Email
afung@cochlear.com
First Name & Middle Initial & Last Name & Degree
Nicolas Verhaert, Doctor
Facility Name
Cochlear Technology Centre Belgium
City
Mechelen
ZIP/Postal Code
B-2800
Country
Belgium
Individual Site Status
Enrolling by invitation
Facility Name
ENT Department, Sint-Augutinus Antwerp
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Fung
Phone
3038807305
Email
afung@cochlear.com
First Name & Middle Initial & Last Name & Degree
Andrzej Zarowski, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

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A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.

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