Clinical trial NCT05003674: A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
Official title: A Feasibility, Prospective, Multi-centre, Repeated-measures Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment
Keywords: cochlear implantation
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This feasibility study is designed to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP) stimulation within a group of adult cochlear-implant recipients. Measures of speech recognition, music appreciation, listening effort, quality of life, and real-world assessments will be gathered to determine the most promising benefits for further examination.

Detailed description: Alternative modes of stimulation will be investigated that may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical benefits over MP stimulation. The purpose of this feasibility study is to explore several facets of hearing performance that may show improvements with these alternative modes of stimulation compared to MP stimulation within a group of adult cochlear-implant recipients. Measures of speech recognition, music appreciation, listening effort, quality of life, and real-world assessments will be gathered to determine the most promising benefits for further examination. Individual neural, psychophysical, cognitive, and electrode placement data will also be obtained to inform questions related to across-subject variability, and practical aspects of power consumption and device fitting will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Adults 18 years of age or older.
2. Candidate for unilateral cochlear implant with Slim Modiolar electrode array as determined by the implanting centre.
3. English spoken as a primary language.
4. Willingness to comply with all investigational requirements.
5. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Previous or existing cochlear-implant recipient.
2. Evidence of severe or greater sensorineural hearing loss prior to five years of age.
3. Open-set pre-operative word score \> 70% in the contralateral ear.
4. Duration of severe to profound hearing loss \> 20 years in the ear to be implanted.
5. Adults with functional acoustic hearing in the ear to be implanted who desire to use an acoustic component in the implanted ear.
6. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
7. Hearing loss of neural or central origin.
8. Medical or psychological conditions that would contraindicate undergoing surgery.
9. Women who are pregnant.
10. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
11. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
12. Inability or unwillingness to use a hand-held device to control the sound processor and to collect test and survey data.
13. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
14. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
15. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
16. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Primary outcomes:
measure: Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Deakin
country: Australia
facility: NextSense - Deakin
state: Australian Capital Territory
city: Broadmeadow
country: Australia
facility: NextSense - Broadmeadow
state: New South Wales
city: East Melbourne
country: Australia
facility: Royal Victorian Eye and Ear Hospital
state: Victoria
city: East Melbourne
country: Australia
facility: St Vincent's Private Hospital
state: Victoria
Study officials:
References: