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Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults

Primary Purpose

Sensorineural Hearing Loss

Status

Completed

Phase

Locations

United States

Study Type

Interventional

Intervention

Hybrid SRW cochlear implant

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring Adults; high frequency SNHL

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eighteen years of age or older at the time of implantation
Sensorineural hearing loss with the following requirements: a pure tone threshold less (better) than or equal to 60 dB HL at 500 Hz,less than (better) or equal to 80 dB HL at 1500 Hz, and high frequency severe to profound (a threshold average of 2000, 3000, & 4000 Hz) of > 60dB HL.
Minimum of 30 days experience with appropriately fit bilateral amplification, fit as described in the Fitting and Use of Hearing Aids section below
Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) between 20% and 60%, inclusive (i.e., 20% score 60%), in the ear to be implanted
Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%
Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through 12-months post-activation

Exclusion Criteria:

Individuals aged greater than 75 years
Duration of severe to profound hearing loss (above 2kHz) greater than 20 years
Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
Conductive overlay of 15 dB or greater at two or more frequencies, in the range 500 to 1000 Hz
Deafness due to lesions of the acoustic nerve or central auditory pathway
Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.

Sites / Locations

University of Iowa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implanted

Arm Description

Subjects will be implanted with the Hybrid SRW cochlear implant.

Outcomes

Primary Outcome Measures

CNC (Consonant-nucleus-consonant) Words

Two CNC( consonant-nucleus-consonant) Word lists (Peterson & Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome.

Secondary Outcome Measures

Full Information

NCT ID

NCT02638883

First Posted

December 3, 2015

Last Updated

September 5, 2022

Sponsor

Cochlear

Collaborators

University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT02638883

Brief Title

Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults

Official Title

Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

February 8, 2016 (Actual)

Primary Completion Date

June 12, 2019 (Actual)

Study Completion Date

June 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cochlear

Collaborators

University of Iowa

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.

Detailed Description

The Food and Drug Administration recently approved the Cochlear Nucleus Hybrid L24 Implant System (P130016) for individuals aged 18 years and older who present with bilateral residual low frequency hearing sensitivity and severe to profound high frequency sensorineural hearing loss with limited benefit from appropriately fitted bilateral amplification. Additionally, the Nucleus Hybrid S12 Implant has been under evaluation since 2007 (IDE G#070016). The Nucleus Hybrid S-RW is a modification of the current Hybrid S12 implant. The Hybrid S-RW is designed to support implantation via a round window (RW) approach while maintaining the same relative insertion depth as the previous Hybrid S12 when implanted via cochleostomy

6. Conditions and Keywords

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

Sensorineural Hearing Loss

Keywords

Adults; high frequency SNHL

7. Study Design

Primary Purpose

Treatment

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Implanted

Arm Type

Experimental

Arm Description

Subjects will be implanted with the Hybrid SRW cochlear implant.

Intervention Type

Device

Intervention Name(s)

Hybrid SRW cochlear implant

Intervention Description

Subjects will be implanted with the Hybrid SRW

Primary Outcome Measure Information:

Title

CNC (Consonant-nucleus-consonant) Words

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eighteen years of age or older at the time of implantation Sensorineural hearing loss with the following requirements: a pure tone threshold less (better) than or equal to 60 dB HL at 500 Hz,less than (better) or equal to 80 dB HL at 1500 Hz, and high frequency severe to profound (a threshold average of 2000, 3000, & 4000 Hz) of > 60dB HL. Minimum of 30 days experience with appropriately fit bilateral amplification, fit as described in the Fitting and Use of Hearing Aids section below Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) between 20% and 60%, inclusive (i.e., 20% score 60%), in the ear to be implanted Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80% Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through 12-months post-activation Exclusion Criteria: Individuals aged greater than 75 years Duration of severe to profound hearing loss (above 2kHz) greater than 20 years Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array Conductive overlay of 15 dB or greater at two or more frequencies, in the range 500 to 1000 Hz Deafness due to lesions of the acoustic nerve or central auditory pathway Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.

Facility Information:

Facility Name

University of Iowa

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15035561

Citation

Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.

Results Reference

background

PubMed Identifier

23651462

Citation

Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: the SSQ12. Int J Audiol. 2013 Jun;52(6):409-12. doi: 10.3109/14992027.2013.781278.

Results Reference

background

PubMed Identifier

14485785

Citation

PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.

Results Reference

background

PubMed Identifier

21829134

Citation

Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.

Results Reference

background

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Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults

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