Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT04707885

Conditions

Hearing Loss, Sensorineural

Hearing Loss

Hearing Loss, Bilateral

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Electrocochleography

Study Details

Brief summary:

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).

Conditions

Hearing Loss, Sensorineural

Hearing Loss

Hearing Loss, Bilateral

Study ID

NCT04707885

Start date

Nov 10, 2021

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
3. Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.
4. Limited benefit from conventional amplification in the best aided condition as defined by test scores of:

1. The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
2. Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
5. Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
6. Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.
7. Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.
8. Proficient in English.
9. Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.

1. Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
2. Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
10. Stated willingness and ability to complete testing and all associated study visits.

Exclusion Criteria:

1. Previous cochlear implantation.
2. Prelingual onset of hearing loss.
3. Abnormal inner ear anatomy on CT imaging.
4. Auditory neuropathy spectrum disorder.
5. Retrocochlear pathology such as a vestibular schwannoma or stroke.
6. Unwillingness or inability to comply with all investigational requirements including the randomization process.
7. Additional medical, or social barriers that would prevent completion of all study requirements.
8. Medical condition contraindicated for surgery.
9. Device selection of Med El CI (per the patient's selection).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Electrocochleography

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Beth Miles-Markley

614-366-9244beth.miles-markley@osumc.edu

Meghan Hiss, AuD

meghan.hiss@osumc.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Dan Osland

507-266-1470Osland.Dan@mayo.edu

Principal Investigator:

Colin Driscoll, MD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Sarah Kukuljan

kukuljas@wustl.edu

Principal Investigator:

Amanda Ortmann, PhD

University of North Carolina, Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Kevin Brown, MD

k_d_brown@med.unc.edu

Principal Investigator:

Kevin Brown, MD

Ohio State University Eye and Ear Institute

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Leah Kofmehl

leah.kofmehl@osumc.edu

Principal Investigator:

Edward Dodson, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Sarah Mleziva

smleziva@mcw.edu

Principal Investigator:

Michael Harris, MD

More Information

Sponsor

Ohio State University

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-09-12.