Clinical Investigation of the Nucleus® CI532 Cochlear Implant

Hearing Loss Clinical Trial

Official title:

Clinical Investigation of the Nucleus® CI532 Cochlear Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392403
• Other study ID #: CLTD5446
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2017
• 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 and to demonstrate the atraumatic nature of the electrode design.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eighteen years of age or older at the time of implantation

• Conventional candidate for cochlear implantation with a perimodiolar electrode array according to local criteria (excepting the exclusion criteria that follow)

• Native speaker in the local language used to assess clinical performance

Exclusion Criteria:

• Evidence of hearing loss prior to 5 years of age

• Prior cochlear implantation; i.e. having a cochlear implant in the contralateral ear, or previously implanted in either ear

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

• Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination

• 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 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 such as undergoing a post-operative digital volume tomography/ConeBeam scan

• Patients with existing Cerebral Spinal Fluid shunts or drains, existing perilymph fistula, skull fracture or Cerebral Spinal Fluid leak

• Patients with recurrent episodes of bacterial meningitis

• Pregnancy or breast-feeding

• Known allergies to components of the implant

• Wearing other active implants with known interference with cochlear implants

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Nucleus CI532 cochlear implant

Locations

Country	Name	City	State
Australia	The HEARing CRC	Melbourne	Victoria
France	Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan	Toulouse	Midi-Pyrénées
Germany	Ear, Nose and Throat Department, Universitätsklinikum Erlangen	Erlangen	Bavaria
Germany	Klinikum der J. W. Goethe-Universität Frankfurt	Frankfurt am Main	Hessen
Germany	Ear, Nose and Throat Department, University of Freiburg	Freiburg	Baden-Württemberg
Germany	Ear, Nose and Throat Department, Medizinische Hochschule	Hannover	Niedersachsen
Germany	Universitätsklinikum Schleswig-Holstein - Campus Kiel	Kiel	Schleswig-Holstein
Spain	Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas	Gran Canaria

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Countries where clinical trial is conducted

Australia,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan	The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.	up to one month post-surgery
Secondary	Array Proximity to the Modiolus Measured Using the Wrapping Factor	The ratio of the active array length and the corresponding lateral wall length	up to one month post-surgery
Secondary	Surgeon Questionnaire on Implant Surgery	To collect experiences using the CI532. At each surgery, the surgeon was asked whether "overall the CI532 was easy to handle and the EA32 easy to insert". We counted the number of surgeons who strongly agreed or who agreed.	at time of surgery
Secondary	Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months	Change in percent correct speech recognition test scores for implant ear alone and best aided	baseline and 6 months post activation
Secondary	Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire	The Glasgow Benefit Inventory is a single time point measure of patient reported benefit.; A score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100.	6 months post activation
Secondary	Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months	Rating scale. 0=worst; 10=best	baseline and 6 months post activation
Secondary	Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months	We report only the change for the 500 Hz frequency.	baseline and 6 months post activation
Secondary	Number of Adverse Events at Surgery		at time of surgery
Secondary	Number of Adverse Events Post Surgery to 6 Months Post-activation		post surgery to 6 months post-activation