Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Conditions

• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• Electrocochleography — DEVICE
  The use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component. For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at \~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions.

Study Details

The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).

Key Dates

Start date

Nov 10, 2021

Status verified

Sep 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ECochG monitoring
  For those randomized to the experimental group, the CI surgery will proceed in a standard fashion. However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components. Also, a sound applicator (i.e. speaker) will be placed in the external auditory canal by the surgeon. During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed. That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH.
• No Intervention: Control Group
  For those randomized to the control group, they will receive their CI per the standard of care. That is, all procedures that take place during a routine CI surgery will be the same for those in the control group. As such, no ECochG monitoring will be performed. However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring. Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea. Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions.

Primary Outcome Measure

Preservation Advantage [ Time Frame: 3, 6, 12, 24 months ]

Central Contacts

• Beth Miles-Markley
  614-366-9244
  [email protected]
• Meghan Hiss, AuD
  [email protected]

Locations (5)

Find similar trials in Rochester, MN

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