An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients (SONORA-MU)

Cochlear

Status: Not yet enrolling

Conditions: Cochlear Implant Recipients; Hearing Loss, Cochlear

Treatments: Device: Investigational sound coding strategy; Device: Cochlear default sound coding strategy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06867380

AI5838

Details and patient eligibility

About

This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Users of an approved Nucleus cochlear implant.
• Aged 18 years or older (no upper age limit).
• Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
• Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
• Willing and able to provide written informed consent.

Exclusion criteria

• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
• Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
• 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: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

Investigational sound coding strategy/Default sound coding strategy (Sub A)

Experimental group

Description:

Tested with investigational and default sound coding strategies

Treatment:

Device: Cochlear default sound coding strategy

Device: Investigational sound coding strategy