A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.

Hearing Impairment, Sensorineural Clinical Trial

— SASC  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641155
• Other study ID #: AI5781
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: July 2023
• Source: Cochlear
• Contact: Amy Fung
• Phone: 3038807305
• Email: afung[@]cochlear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment, Sensorineural
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Focused Multipolar Stimulation (FMS) strategy
Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	Cochlear Technology Centre Belgium	Mechelen
Belgium	ENT Department, Sint-Augutinus Antwerp	Wilrijk
United States	Rocky Mountain Ear Center	Englewood	Colorado
United States	Denver Research and Technology Lab	Lone Tree	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference across maximum map stimulation (C) levels	Mean difference across maps using alternative modes and sound coding parameters for the highest and average comfortable loudness level (clinical unit) (C-level).	10 weeks
Primary	Mean difference across Spectral resolution (QSMD)	Mean difference across maps using alternative modes and sound coding parameters for spectral resolution (% correct) (QSMD - Quick spectral modulation detection)	10 weeks
Primary	Mean difference across phoneme discrimination (LIT- Language independent test)	Mean difference across maps using alternative modes and sound coding parameters for phoneme discrimination (% correct) (LIT - Language independent test)	10 weeks