Stimulating the Cochlear Apex Without Longer Electrodes

NYU Langone Health

Status: Enrolling

Conditions: Deafness With a Cochlear Implant

Treatments: Procedure: Modified surgical approach; Device: Cochlear Nucleus CI632 cochlear implant

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06901674

20-01964

5R21DC019743-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear unstimulated. Providing stimulation over the entire cochlea has the potential to improve speech understanding, sound quality, as well as spectral and temporal representation. Increasing the length of the electrode array to cover a greater portion of the cochlea has many potential issues, including increased damage to the cochlea and probability of incomplete insertions. In this study, a new technique is being investigated that allows stimulation across the entire cochlear extent without increasing the length of the electrode array. The purpose of this study is to evaluate the benefit of the new technique on speech understanding outcomes. Additionally, the study will investigate the new configuration to explore how the auditory system encodes temporal and spectral information.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants in this study must have already been evaluated at the NYU cochlear implant center as being eligible for a cochlear implant.
• They must have decided to receive a cochlear implant manufactured by Cochlear Limited and have been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted.
• Individuals who have already been implanted with a cochlear implant manufactured by Cochlear Limited with or without this new approach may also participate in this study.

Exclusion criteria

• They are under the age of 18
• They have not been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted
• Have >15 years of profound deafness
• Have not chosen to receive a cochlear implant manufactured by Cochlear Limited
• Are pregnant or plan to conceive within 6 months of consenting

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Apical ground electrode

Experimental group

Description:

Participants in this group will have already received a cochlear implant using the new approach or be receiving a cochlear implant with the new approach.

Treatment:

Device: Cochlear Nucleus CI632 cochlear implant

Procedure: Modified surgical approach

Standard location ground electrode

Active Comparator group

Description:

Participants in this group have received a cochlear implant with the typical ground electrode placement.

Treatment:

Device: Cochlear Nucleus CI632 cochlear implant