Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents

NCT01975571 | Completed Results

• 1 other identifier: 201106758
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical stimulation through a short cochlear implant. The low-pitches would be amplified with a hearing aid and the high-pitch sounds would be stimulated electrically.

Conditions

Hearing Loss, High-Frequency

Keywords

residual hearing; hybrid; hearing preservation

Outcome Measures

Primary Outcomes (1)

• Change in CNC Word Perception

  Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted): Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears) Testing will be in quiet at 60 dB(A). The CNC word perception test consists of multiple lists of 50 3-syllable words (consonant-nucleus-consonant) that are presented through a loudspeaker using an open set format. Percent correct is calculated by the number of words identified by the subject out of the 50 words presented.

  pre-op, 3, 6, 12, 24 months in the adults and pre-op, 3, 6, 12, 24, 36, 48, and 60 months post-implantation for children

Secondary Outcomes (2)

• Change in Localization

  Preoperatively and at 6 and 24 months post op in adults and pre op and 12 and 24 mos in children

• AzBio +5 Noise

  Adults pre-op, 3, 6, 12, 24 months post op

Study Arms (3)

Adult

EXPERIMENTAL

Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid L24 cochlear implant.

Device: Cochlear® Nucleus™ Hybrid L24

Children and adolescents (L24)

EXPERIMENTAL

Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold \>90 dB HL at 1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid L24 cochlear implant.

Device: Cochlear® Nucleus™ Hybrid L24

Children and adolescents S12

EXPERIMENTAL

Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid S12 cochlear implant.

Device: Cochlear® Nucleus™ Hybrid S12

Interventions

Cochlear® Nucleus™ Hybrid L24 DEVICE

The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.

Adult; Children and adolescents (L24)

Cochlear® Nucleus™ Hybrid S12 DEVICE

The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.

Children and adolescents S12

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eighteen year of age or older at the time of implantation.
• Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
• Speech Perception:
• The Consonant-Nucleus-Consonant (CNC) word recognition score between 0% and 35% inclusive in the ear to be implanted.
• The CNC word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60% in the best-aided condition.
• English spoken as a primary language.
• Willingness to comply with all study requirements.
• Minimum of 30 day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day).
• Patent cochlea and normal cochlear anatomy.
• Five to fifteen years of age at the time of implantation.
• Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
• Speech Perception:
• The Phonetically Balanced-Kindergarten (PB-K) word recognition score between 0% and 50% inclusive in the ear to be implanted.
• The PB-K word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60%.
• English spoken as a primary language.

You may not qualify if:

• Medical or psychological conditions that contraindicate undergoing surgery.
• Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
• Unrealistic expectations on the part of the candidate and/or candidate's family, 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.
• Active middle ear infection.

Sponsors & Collaborators

• Bruce J Gantz: lead

Study Sites (2)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Hearing Loss, High-Frequency

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: Dr. Camille Dunn
• Organization: University of Iowa

camille-dunn@uiowa.edu

3193538776

Study Officials

• Bruce Gantz, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: November 4, 2013
• Study Start: July 1, 2011
• Primary Completion: September 8, 2018
• Study Completion: September 8, 2018
• Last Updated: June 8, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-05

Locations

US (2)