Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients (DUAL)

Cochlear

Status: Completed

Conditions: Hearing Loss, Sensorineural

Treatments: Device: Program using low-power 3 (LP3) MAP; Device: Program using low-power 1 (LP1) MAP; Device: Program using default MAP; Device: Program using low-power 2 (LP2) MAP

Study type: Interventional

Funder types: Industry

Identifiers

NCT06298396

CLTD5853

Details and patient eligibility

About

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.

Full description

Performance of four programs (MAPs), each with a different rate, PW and stimulation mode were evaluated, all using 8 maxima: (i) 900 Hz rate, 25 µs PW Default (ii) 900 Hz rate, 50 µs PW LP1, (iii) 500 Hz rate, 100 µs PW LP2 all using Monopolar stimulation mode, and (iv) 500 Hz rate, 100 µs PW using an investigational stimulation mode LP3

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422)
• At least three months after activation of the cochlear implant.
• Eighteen years or older at the time of consent.
• User of 900Hz ACE (Advanced Combination Encoder) strategy MAP.
• Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear.
• Fluent speaker in English.
• Willing and able to provide written informed consent.

Exclusion criteria

• One or more electrodes turned off in the MAP used regularly.
• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors

Experimental group

Description:

Participants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP.

Treatment:

Device: Program using low-power 2 (LP2) MAP

Device: Program using default MAP

Device: Program using low-power 1 (LP1) MAP

Device: Program using low-power 3 (LP3) MAP