Implantation With the Nucleus CI532 Cochlear Implant in Adults

Hearing Loss Clinical Trial

Official title:

Implantation With the Nucleus CI532 Cochlear Implant in Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02677220
• Other study ID #: CAM5631
• Status: Terminated
• Phase: N/A
• Start date: May 11, 2016
• Est. completion date: August 23, 2017

Study information

• Verified date: February 2019
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant.

The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.

Other known NCT identifiers

• NCT02560987

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 23, 2017
• Est. primary completion date: August 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet current cochlear implant criteria at the implanting center

• 18 years or older with bilateral sensorineural hearing loss

• Limited benefit from appropriate binaural hearing aids

• Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies

• Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted

• Fluent speaker in the language used to assess clinical performance

Exclusion Criteria:

• Evidence of hearing loss prior to age 5

• Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz

• Simultaneous bilateral implantation prior to the study

• Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery

• Cochlear anomaly that might prevent complete insertion of the electrode array

• Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway

• Active middle ear infection

• Tympanic membrane perforation

• Unrealistic expectations

• Unwillingness or inability co comply with all investigational requirements

• Patients with existing cerebral shunts or drains

• Recurrent episodes of bacterial meningitis

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• CI532 cochlear implant

Locations

Country	Name	City	State
United States	NYU Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AzBio Sentence Recognition in Noise	The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests 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 toward the overall score and the resulting score is presented in percent correct.	3 months post-activation
Secondary	Glasgow Benefit Inventory	The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100.	6 months post-activation
Secondary	Speech, Spatial, and Qualities of Hearing Scale	The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10).	6 months post-activation