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

NCT02638883 | Completed Results

• 1 other identifier: CAM 5630
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorineural Hearing Loss

Keywords

Adults; high frequency SNHL

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

Implanted

EXPERIMENTAL

Subjects will be implanted with the Hybrid SRW cochlear implant.

Device: Hybrid SRW cochlear implant

Interventions

Hybrid SRW cochlear implant DEVICE

Subjects will be implanted with the Hybrid SRW

Implanted

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead
• University of Iowa: collaborator

Study Sites (1)

University of Iowa

Des Moines, Iowa, 52242, United States

Location

Related Publications (4)

• 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.

  PMID: 15035561 BACKGROUND

• 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.

  PMID: 23651462 BACKGROUND

• 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.

  PMID: 14485785 BACKGROUND

• 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.

  PMID: 21829134 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: PRS Specialist, Clinical Affairs
• Organization: Cochlear Limited

cltd-prs-admin@cochlear.com

+612 9428 6555

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 23, 2015
• Study Start: February 8, 2016
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: September 27, 2022
• Results First Posted: September 27, 2022

Record last verified: 2022-09

Locations

US (1)