Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

NCT00678899 | Completed Results

• 1 other identifier: CORP5180
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the Nucleus Hybrid L24 cochlear implant system.

Conditions

Sensorineural Hearing Loss

Keywords

High frequency severe to profound

Outcome Measures

Primary Outcomes (2)

• Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)

  The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study.

  6 Months Postactivation

• AzBio Sentence Score in Noise - Treated Ear (Co-Primary)

  The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score.

  6 Months Postactivation

Secondary Outcomes (2)

• Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear

  6 Months Postactivation

• AzBio Sentence Score-Treated Ear

  6 Months Postactivation

Study Arms (1)

Surgery

EXPERIMENTAL

Implantation with the Nucleus Hybrid L24 Cochlear Implant

Device: Nucleus Hybrid L24

Interventions

Nucleus Hybrid L24 DEVICE

Implantation with Nucleus Hybrid L24 cochlear implant

Surgery

Eligibility Criteria

• Age: 18 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.
• Severe to profound (a threshold average of 2000, 3000, \& 4000 Hz \> 75dB HL) sensorineural hearing loss for frequencies \> 1500 Hz. Low-frequency thresholds up to and including 500 Hz should be no poorer than 60 dB HL.
• Consonant Nucleus Consonant (CNC) monosyllabic word recognition score (mean of two lists) between 10% and 60%, inclusive (i.e., 10% \<= score \<= 60%), in the ear to be implanted.
• CNC word recognition score in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%.
• English spoken as a primary language.

You may not qualify if:

• Duration of severe-to-profound hearing loss greater than 30 years.
• Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
• Medical or psychological conditions that contraindicate undergoing surgery.
• 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 250 to 1000 Hz.
• Hearing loss of neural or central origin.
• Diagnosis of Auditory Neuropathy.
• Active middle-ear infection.
• 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.
• Unwillingness or inability of the candidate to comply with all investigational requirements.
• Additional handicaps that would prevent or restrict participation in the audiological evaluations.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (1)

NYU Medical Center

New York, New York, 10016, United States

Location

Related Publications (2)

• Reinhart PN, Parkinson AJ, Dunn CC, Gantz BJ. Factors Affecting Audiometric and Speech Perception Outcomes in Hybrid Cochlear Implant Recipients. Laryngoscope. 2025 Oct 8. doi: 10.1002/lary.70195. Online ahead of print.

  PMID: 41059917 DERIVED

• Roland JT Jr, Gantz BJ, Waltzman SB, Parkinson AJ. Long-term outcomes of cochlear implantation in patients with high-frequency hearing loss. Laryngoscope. 2018 Aug;128(8):1939-1945. doi: 10.1002/lary.27073. Epub 2018 Jan 13.

  PMID: 29330858 DERIVED

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: Ginger Grant/Clinical Project Manager
• Organization: Cochlear Americas

ggrant@cochlear.com

410-375-0883

Study Officials

• John T Roland, MD

  NYU MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2014
• Last Updated: July 15, 2015
• Results First Posted: September 29, 2014

Record last verified: 2015-06

Locations

US (1)