Clinical Utility of Residual Hearing in the Cochlear Implant Ear

NCT04707885 | Recruiting DMC FDA Device

• 2 other identifiers: 2020H0477U01DC018920-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Preservation Advantage

  Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.

  3, 6, 12, 24 months

Study Arms (2)

ECochG monitoring

EXPERIMENTAL

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.

Device: Electrocochleography

Control Group

NO INTERVENTION

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 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.

Also known as: ECochG

ECochG monitoring

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
• 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.
• Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
• The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
• Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
• Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
• 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.
• 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.
• Proficient in English.
• Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.
• Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
• Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
• Stated willingness and ability to complete testing and all associated study visits.

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (5)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Ohio State University Eye and Ear Institute

Columbus, Ohio, 43210, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (16)

• Eggermont JJ. Ups and Downs in 75 Years of Electrocochleography. Front Syst Neurosci. 2017 Jan 24;11:2. doi: 10.3389/fnsys.2017.00002. eCollection 2017.

  PMID: 28174524 BACKGROUND

• Gantz BJ, Dunn C, Oleson J, Hansen M, Parkinson A, Turner C. Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes. Laryngoscope. 2016 Apr;126(4):962-73. doi: 10.1002/lary.25572. Epub 2016 Jan 12.

  PMID: 26756395 BACKGROUND

• Gantz BJ, Hansen MR, Turner CW, Oleson JJ, Reiss LA, Parkinson AJ. Hybrid 10 clinical trial: preliminary results. Audiol Neurootol. 2009;14 Suppl 1(Suppl 1):32-8. doi: 10.1159/000206493. Epub 2009 Apr 22.

  PMID: 19390173 BACKGROUND

• Gautschi-Mills K, Khoza-Shangase K, Pillay D. Preservation of residual hearing after cochlear implant surgery: an exploration of residual hearing function in a group of recipients at cochlear implant units. Braz J Otorhinolaryngol. 2019 May-Jun;85(3):310-318. doi: 10.1016/j.bjorl.2018.02.006. Epub 2018 Mar 24.

  PMID: 29631897 BACKGROUND

• Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the expansion of adult cochlear implant candidacy. Ear Hear. 2010 Apr;31(2):186-94. doi: 10.1097/AUD.0b013e3181c6b831.

  PMID: 20071994 BACKGROUND

• Gstoettner WK, Baumgartner WD, Franz P, Hamzavi J. Cochlear implant deep-insertion surgery. Laryngoscope. 1997 Apr;107(4):544-6. doi: 10.1097/00005537-199704000-00022. No abstract available.

  PMID: 9111389 BACKGROUND

• Gstoettner W, Helbig S, Settevendemie C, Baumann U, Wagenblast J, Arnoldner C. A new electrode for residual hearing preservation in cochlear implantation: first clinical results. Acta Otolaryngol. 2009 Apr;129(4):372-9. doi: 10.1080/00016480802552568.

  PMID: 19140036 BACKGROUND

• Campbell L, Kaicer A, Sly D, Iseli C, Wei B, Briggs R, O'Leary S. Intraoperative Real-time Cochlear Response Telemetry Predicts Hearing Preservation in Cochlear Implantation. Otol Neurotol. 2016 Apr;37(4):332-8. doi: 10.1097/MAO.0000000000000972.

  PMID: 26859542 BACKGROUND

• Herz A, Niedner I, Fraling F, Sommer-Smith J. [Cortical and subcortical reaction potentials after sensory stimulation in wakefull and sleeping cat]. Exp Brain Res. 1966;1(3):249-64. doi: 10.1007/BF00234345. No abstract available. German.

  PMID: 5920552 BACKGROUND

• Hodges AV, Schloffman J, Balkany T. Conservation of residual hearing with cochlear implantation. Am J Otol. 1997 Mar;18(2):179-83.

  PMID: 9093674 BACKGROUND

• Koka K, Saoji AA, Litvak LM. Electrocochleography in Cochlear Implant Recipients With Residual Hearing: Comparison With Audiometric Thresholds. Ear Hear. 2017 May/Jun;38(3):e161-e167. doi: 10.1097/AUD.0000000000000385.

  PMID: 27879487 BACKGROUND

• Lan KK, DeMets DL. Changing frequency of interim analysis in sequential monitoring. Biometrics. 1989 Sep;45(3):1017-20.

  PMID: 2790114 BACKGROUND

• Pillsbury HC 3rd, Dillon MT, Buchman CA, Staecker H, Prentiss SM, Ruckenstein MJ, Bigelow DC, Telischi FF, Martinez DM, Runge CL, Friedland DR, Blevins NH, Larky JB, Alexiades G, Kaylie DM, Roland PS, Miyamoto RT, Backous DD, Warren FM, El-Kashlan HK, Slager HK, Reyes C, Racey AI, Adunka OF. Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. Otol Neurotol. 2018 Mar;39(3):299-305. doi: 10.1097/MAO.0000000000001691.

  PMID: 29342054 BACKGROUND

• Saoji AA, Patel NS, Carlson ML, Neff BA, Koka K, Tarigoppula VSA, Driscoll CLW. Multi-frequency Electrocochleography Measurements can be Used to Monitor and Optimize Electrode Placement During Cochlear Implant Surgery. Otol Neurotol. 2019 Dec;40(10):1287-1291. doi: 10.1097/MAO.0000000000002406.

  PMID: 31644474 BACKGROUND

• Scheperle RA, Tejani VD, Omtvedt JK, Brown CJ, Abbas PJ, Hansen MR, Gantz BJ, Oleson JJ, Ozanne MV. Delayed changes in auditory status in cochlear implant users with preserved acoustic hearing. Hear Res. 2017 Jul;350:45-57. doi: 10.1016/j.heares.2017.04.005. Epub 2017 Apr 12.

  PMID: 28432874 BACKGROUND

• Skinner MW, Holden TA, Whiting BR, Voie AH, Brunsden B, Neely JG, Saxon EA, Hullar TE, Finley CC. In vivo estimates of the position of advanced bionics electrode arrays in the human cochlea. Ann Otol Rhinol Laryngol Suppl. 2007 Apr;197:2-24.

  PMID: 17542465 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss; Hearing Loss, Bilateral

Interventions

Audiometry, Evoked Response

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Audiometry; Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Oliver Adunka, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Amanda Ortmann, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Miles-Markley

CONTACT

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

Meghan Hiss, AuD

CONTACT

meghan.hiss@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: November 10, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)