Clinical trial NCT05641155: A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.
Official title: An Early Feasibility, Prospective, Exploratory Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding Enhancements in Adult Cochlear Implant Recipients (SASC).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hearing Impairment, Sensorineural
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2022-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this early feasibility study is to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP stimulation) in cochlear implant recipients. This study will iteratively evaluate different parameter sets that intend to maximize hearing performance benefits within technical requirements. This study is exploratory in nature and will achieve its objectives through ongoing review and adjustment of device parameters and fitting

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 study is to balance the clinical improvements of alternative modes of stimulation with technical and usability requirements for power usage. By iteratively evaluating different sets of stimulation and sound coding parameters, this study will determine device settings and fitting techniques. Measures of speech recognition, listening effort, neural responses, electrode placement, battery life, and usability acceptance will be obtained to evaluate clinical benefits

Eligibility criteria: Inclusion Criteria:

1) Candidate for unilateral cochlear implantation according to bilateral sensorineural hearing loss criteria, who has decided to proceed with implantation through routine processes.

a) Bilateral sensorineural hearing loss criteria for clinics in the United States: i) Ear to be implanted:

1. Moderate to profound sensorineural hearing loss, defined as a pure-tone average (PTA) (250 - 1000 Hz) ≥ 40 dB HL and a PTA (2000 - 8000 Hz) ≥ 65 dB HL
2. Aided word score ≤ 40% ii) Contralateral ear:

(1) PTA (500, 1000, 2000, and 4000 Hz) \> 30 dB HL (2) Aided word score ≤ 80% b) Bilateral sensorineural hearing loss criteria for clinics in Belgium: i) Both ears:

1. PTA (500, 1000, 2000, and 4000 Hz) ≥ 70 dB HL for average of 3 out of 4 frequencies
2. Unaided phoneme score ≤ 50% on CVC in quiet at 70 dB SPL in free field
3. ABR peak ≥ 75 dB nHL

2) 18 years of age or older.

3) Fluent in the language used for speech testing.

4) Willing to comply with all investigational requirements.

5) Willing and able to provide written informed consent

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Exclusion Criteria:

1. Previous or existing cochlear-implant recipient.
2. Severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
3. Duration of severe to profound hearing loss \> 20 years in the ear to be implanted.
4. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
5. Diagnosis of auditory neuropathy.
6. Deafness due to lesions of the acoustic nerve or central auditory pathway.
7. Pregnant at the time of surgery.
8. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
9. 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.
10. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
11. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
12. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
13. 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 across maximum map stimulation (C) levels
timeFrame: 10 weeks
measure: Mean difference across Spectral resolution (QSMD)
timeFrame: 10 weeks
measure: Mean difference across phoneme discrimination (LIT- Language independent test)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Rocky Mountain Ear Center
state: Colorado
city: Lone Tree
country: United States
facility: Denver Research and Technology Lab
state: Colorado
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Mechelen
country: Belgium
facility: Cochlear Technology Centre Belgium
city: Wilrijk
country: Belgium
facility: ENT Department, Sint-Augutinus Antwerp
Study officials:
References: