Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

Hearing Loss, Sensorineural Clinical Trial

— SME  

Official title:

Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007472
• Other study ID #: CLTD5685
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: March 6, 2020

Study information

• Verified date: December 2020
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

Description:

Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 6, 2020
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.

2. Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level.

3. Bilateral moderate sloping to profound hearing loss

4. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method

5. Proficient in English

6. Ability to complete testing -

Exclusion Criteria:

1. Previous cochlear implantation

2. Pre-linguistically deafened (onset of hearing loss at less than two years of age)

3. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array

4. Duration of severe to profound hearing loss greater than 20 years

5. Diagnosis of retro-cochlear pathology

6. Diagnosis of auditory neuropathy

7. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device

8. Unwillingness or inability to comply with all investigational requirements

9. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements-

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• CI532
Cochlear implant
• Nucleus 7
Sound processor

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	The Center for Hearing and Balance Disorders	Chesterfield	Missouri
United States	The Ohio State University	Columbus	Ohio
United States	Dallas Ear Institute	Dallas	Texas
United States	Rocky Mountain Ear Center	Englewood	Colorado
United States	University of Iowa	Iowa City	Iowa
United States	Midwest Ear Institute	Kansas City	Missouri
United States	New York University	New York	New York
United States	Hearts for Hearing	Oklahoma City	Oklahoma
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

References & Publications (6)

Grutters JP, Joore MA, van der Horst F, Verschuure H, Dreschler WA, Anteunis LJ. Choosing between measures: comparison of EQ-5D, HUI2 and HUI3 in persons with hearing complaints. Qual Life Res. 2007 Oct;16(8):1439-49. Epub 2007 Jul 24. — View Citation

Hiller W, Goebel G. Factors influencing tinnitus loudness and annoyance. Arch Otolaryngol Head Neck Surg. 2006 Dec;132(12):1323-30. — View Citation

Meinert,C(1986).ClinicalTrials:Design,Conduct,andAnalysis.OxfordUniversityPress,NewYork.

Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency Specific Thresholds and Speech Recognition in Noise or Quiet	Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone.	12 months post-activation
Other	Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming	Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise.	Following 12-month study visit but prior to 36-month interval.
Primary	Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone	Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.	Preoperatively and 6 months post sound processor activation
Secondary	Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone	Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.	Preoperatively and 6 months post sound processor activation
Secondary	Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)	Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).	Preoperatively and 6 months post sound processor activaton