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Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness (PAS-SSD)

Primary Purpose

Hearing Loss, Unilateral, Deafness, Unilateral

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Cochlear™ Nucleus® Cochlear Implant (CI) System
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Unilateral

Eligibility Criteria

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

Inclusion Criteria:

• Individuals 18 years or older (Group A)

Ear to be Implanted:

Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

• Children 5 years to 17 years, 11 months (Group B)

Ear to be Implanted:

Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

  • Previous experience with a current conventional treatment option for unilateral [SSD] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required
  • English spoken as a primary language
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Previous cochlear implantation
  • Hearing loss of neural or central origin, including auditory neuropathy
  • Duration of profound sensorineural HL >10 years per self-report
  • Active / chronic middle-ear infection; conductive HL in either ear
  • Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
  • Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator
  • Evidence of and/or suspected cognitive or developmental concern
  • 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 (CROs) or contractors engaged by Cochlear for the purposes of this investigation
  • Pregnant or breastfeeding women
  • Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Sites / Locations

  • Stanford UniversityRecruiting
  • Rocky Mountain Ear CenterRecruiting
  • University of IowaRecruiting
  • New York Eye and Ear InfirmaryRecruiting
  • University of North CarolinaRecruiting
  • Nationwide Children's Hospital
  • University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
  • Virginia Mason Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Children and adults with unilateral hearing loss/single-sided deafness

Arm Description

Outcomes

Primary Outcome Measures

Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.
Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to poorer ear.
Number of procedure and device related adverse events classified by type, frequency and severity.

Secondary Outcome Measures

Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
Assessed via Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire (parent or participant version dependent on age). Rating ranges from 0 (no ability) to 10 (complete ability). Higher scores indicate greater perceived abilities.
Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone.
Measured via the Consonant-Nucleus-Consonant (CNC) Word Recognition Test. The score is the total number of words correct expressed as percent correct (range of 0-100); higher score is better.

Full Information

First Posted
March 17, 2022
Last Updated
September 20, 2023
Sponsor
Cochlear
Collaborators
NAMSA
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1. Study Identification

Unique Protocol Identification Number
NCT05318417
Brief Title
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Acronym
PAS-SSD
Official Title
A Post-approval, Prospective, Nonrandomized, Single-arm Multicenter Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

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

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 aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Unilateral, Deafness, 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
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children and adults with unilateral hearing loss/single-sided deafness
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
The Cochlear™ Nucleus® Cochlear Implant (CI) System
Intervention Description
The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear. External components: The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.
Primary Outcome Measure Information:
Title
Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.
Description
Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to poorer ear.
Time Frame
pre-implantation, 12 months post-activation
Title
Number of procedure and device related adverse events classified by type, frequency and severity.
Time Frame
36 months post-activation
Secondary Outcome Measure Information:
Title
Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
Description
Assessed via Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire (parent or participant version dependent on age). Rating ranges from 0 (no ability) to 10 (complete ability). Higher scores indicate greater perceived abilities.
Time Frame
pre-implantation, 12 months post-activation
Title
Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone.
Description
Measured via the Consonant-Nucleus-Consonant (CNC) Word Recognition Test. The score is the total number of words correct expressed as percent correct (range of 0-100); higher score is better.
Time Frame
pre-implantation, 12 months post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Individuals 18 years or older (Group A) Ear to be Implanted: Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL • Children 5 years to 17 years, 11 months (Group B) Ear to be Implanted: Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL Previous experience with a current conventional treatment option for unilateral [SSD] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required English spoken as a primary language Willing and able to provide written informed consent Exclusion Criteria: Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array Previous cochlear implantation Hearing loss of neural or central origin, including auditory neuropathy Duration of profound sensorineural HL >10 years per self-report Active / chronic middle-ear infection; conductive HL in either ear Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator Evidence of and/or suspected cognitive or developmental concern 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 (CROs) or contractors engaged by Cochlear for the purposes of this investigation Pregnant or breastfeeding women 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
Kathryn Henion
Phone
210-238-8094
Email
khenion@cochlear.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jillian Crosson
Phone
601-209-8781
Email
jcrosson@cochlear.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jillian Crosson
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer C Alyono, MD
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
Allison Biever, AuD
Phone
303-806-6293
Email
allisonb@rockymountainearcenter.com
Facility Name
University of Iowa
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
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namrata Marjit
Phone
929-489-9611
Email
Namrata.Marjit@mountsinai.org
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
919-966-5251
Email
ciresearch@unc.edu
First Name & Middle Initial & Last Name & Degree
Kevin Brown, MD
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Withdrawn
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Stevens
Phone
206-287-6267
Email
Leslie.stevens@virginiamason.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Learn more about this trial

Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

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