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Single-Sided Deafness in the Medicare Population

Primary Purpose

Hearing Loss, Unilateral

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MED-EL Cochlear Implant System
Sponsored by
Med-El Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Unilateral

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 65 years of age or older at the time of implantation
  • Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
  • Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz
  • Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less
  • Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
  • Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
  • Fluent in English

Exclusion Criteria:

  • Duration of profound hearing loss of 10 years or more
  • Sudden onset of hearing loss within six months of implantation
  • Evidence of non-functional cochlear nerve or other retrocochlear hearing loss
  • Evidence of severe cochlear malformation (i.e., common cavity or ossification)
  • External or middle ear infection
  • Suspected cognitive concern
  • Other medical contraindication for surgery or anesthesia

Sites / Locations

  • University of Iowa Hospitals and ClinicsRecruiting
  • University of North CarolinaRecruiting
  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Procedure

Arm Description

Outcomes

Primary Outcome Measures

Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation.
The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.

Secondary Outcome Measures

Performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through one year (12 months) post implantation.
Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 6- and 12-months post activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear. (Range of score 0-100, higher score is better)
Performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through one year (12 months ) post implantation.
Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 6-month, and 12-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better)
Subjective benefit of the Cochlear Implant System will be assessed through one year (12 months) post implantation.
Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 6-month, and 12-month intervals. (Range of score 0-10, lower score is better)
Safety will be evaluated for all study subjects through one year (12 months) post implantation.
Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event.

Full Information

First Posted
February 11, 2022
Last Updated
May 15, 2023
Sponsor
Med-El Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05250414
Brief Title
Single-Sided Deafness in the Medicare Population
Official Title
Cochlear Implantation in the Single-Sided Deafness in the Medicare Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Med-El Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
Detailed Description
The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Study Procedure
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
MED-EL Cochlear Implant System
Intervention Description
Cochlear implant and audio processor
Primary Outcome Measure Information:
Title
Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation.
Description
The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.
Time Frame
One year (12 months) post implantation
Secondary Outcome Measure Information:
Title
Performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through one year (12 months) post implantation.
Description
Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 6- and 12-months post activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear. (Range of score 0-100, higher score is better)
Time Frame
One year (12 months) post implantation
Title
Performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through one year (12 months ) post implantation.
Description
Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 6-month, and 12-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better)
Time Frame
One year (12 months) post implantation
Title
Subjective benefit of the Cochlear Implant System will be assessed through one year (12 months) post implantation.
Description
Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 6-month, and 12-month intervals. (Range of score 0-10, lower score is better)
Time Frame
One year (12 months) post implantation
Title
Safety will be evaluated for all study subjects through one year (12 months) post implantation.
Description
Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event.
Time Frame
One year (12 months) post implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 65 years of age or older at the time of implantation Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator Fluent in English Exclusion Criteria: Duration of profound hearing loss of 10 years or more Sudden onset of hearing loss within six months of implantation Evidence of non-functional cochlear nerve or other retrocochlear hearing loss Evidence of severe cochlear malformation (i.e., common cavity or ossification) External or middle ear infection Suspected cognitive concern Other medical contraindication for surgery or anesthesia
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Dunn, PhD
Phone
319-353-8776
Email
camille-dunn@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Catherine Marini
Email
catherine-marini@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Camille Dunn, PhD
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Dillon, AuD
Phone
919-966-5251
Email
mdillon@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Margaret Dillon, AuD
First Name & Middle Initial & Last Name & Degree
Meredith Rooth, AuD
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kari Smilsky, M.Cl.Sc.
Phone
416-480-6751
Email
kari.smilsky@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Yasmeen Aboulhawa, CRC
Email
yasmeen.aboulhawa@sri.utoronto.ca
First Name & Middle Initial & Last Name & Degree
Kari Smilsky, M.Cl.Sc.

12. IPD Sharing Statement

Citations:
PubMed Identifier
28188428
Citation
Arndt S, Laszig R, Aschendorff A, Hassepass F, Beck R, Wesarg T. Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss. HNO. 2017 Aug;65(Suppl 2):98-108. doi: 10.1007/s00106-016-0297-5.
Results Reference
background
PubMed Identifier
29732951
Citation
Buss E, Dillon MT, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effects of Cochlear Implantation on Binaural Hearing in Adults With Unilateral Hearing Loss. Trends Hear. 2018 Jan-Dec;22:2331216518771173. doi: 10.1177/2331216518771173.
Results Reference
background
PubMed Identifier
27513880
Citation
Mertens G, De Bodt M, Van de Heyning P. Evaluation of Long-Term Cochlear Implant Use in Subjects With Acquired Unilateral Profound Hearing Loss: Focus on Binaural Auditory Outcomes. Ear Hear. 2017 Jan/Feb;38(1):117-125. doi: 10.1097/AUD.0000000000000359.
Results Reference
background
PubMed Identifier
12544032
Citation
Niparko JK, Cox KM, Lustig LR. Comparison of the bone anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral deafness. Otol Neurotol. 2003 Jan;24(1):73-8. doi: 10.1097/00129492-200301000-00015.
Results Reference
background
PubMed Identifier
18834065
Citation
Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):645-52. doi: 10.1177/000348940811700903.
Results Reference
background
PubMed Identifier
19005250
Citation
Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.
Results Reference
background

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Single-Sided Deafness in the Medicare Population

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