AB-Intra- and Post-Operative Measures of Auditory Function

NCT03685461 | Completed FDA Device

• 1 other identifier: PRO00032101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how the inner ear responds to sound delivered to the ear canal during and after your cochlear implant surgery. This information may be helpful in telling us how well a cochlear implant performs after surgery.

Conditions

Hearing Loss; Cochlear Implant

Keywords

Hearing Loss; Cochlear Implant

Outcome Measures

Primary Outcomes (1)

• The CI electrode's scalar position as indicated by post-operative computed tomography (CT)

  Following cochlear implant surgery a CT scan, optimized for resolution of the CI electrode, will be obtained. This will be merged with routine clinically acquired pre-operative imaging to determine which of the scala the electrode sides in and whether or not there has been any translocation from one scala into another.

  To be performed within one month of cochlear implantation

Secondary Outcomes (1)

• Post-operative hearing performance

  To be collected at post-op clinical visits until 12 months post-op

Study Arms (2)

Arm 1: Audible ECochG Response Off

OTHER

Arm 1: Audible ECochG Response Off This condition is identical to the current standard-of-care for conventional CI surgery used worldwide. The surgeon will perform his or her electrode insertion without ECochG monitoring. Minute manipulations of the electrode are a normal part of conventional electrode insertion; manipulations such as redirecting the insertion vector or slowing down insertion speed will be made, as deemed necessary by the surgeon. A full electrode insertion will be performed, as appropriate. The ECochG responses will be recorded, but the surgeon will be blinded to this information during surgery.

Other: Electrocochleography

Arm 2: Audible ECochG Response On

EXPERIMENTAL

This condition will have the audible ECochG response on and available to the surgeon. In this condition, the surgeon perform a conventional electrode insertion while listening to the running ECochG signal for drop in amplitude (suggesting impending trauma). If no drop is detected, insertion will proceed to the full electrode length according to the standard-of-care. If an ECochG amplitude drop is observed, the surgeon will place this observation in its clinical context and evaluate insertion parameters, (i.e., insertion vector, insertion speed, etc.), customary practice with conventional CI surgery, but here supplemented by the ECochG response. In the case of an ECochG amplitude drop that does not recover, the standard-of-care practice of achieving a full electrode insertion will be followed.

Other: Electrocochleography

Interventions

Electrocochleography OTHER

Electrocochleography is a noninvasive method of monitoring for acoustic evoked electrophysiologic responses from the cochlea. A speaker in the external auditory canal presents a tone burst stimulus and a nearby electrode, in this case from the apical electrode of the cochlear implant, records changes in the electrical activity within the cochlea. Different functional elements within the cochlea have signature electrophysiologic responses that can be isolated and studied individually. Through the use of intracochlear electrocochleography during cochlear implant electrode insertion valuable insight can be gained about structural or physiological changes that may be occurring.

Also known as: ECochG

Arm 1: Audible ECochG Response Off; Arm 2: Audible ECochG Response On

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pure-tone audiometry thresholds ≤80 dB HL at 500 Hz
• One year of age and older
• Normal candidacy requirements for cochlear implantation met
• No cochlear abnormality that might prevent full insertion of the CI electrode array
• No additional handicap that would prevent study procedures from being followed

You may not qualify if:

• Chronic otitis media
• Malformed cochlea
• Auditory neuropathy spectrum disorder (ANSD)
• Presence of ear tubes
• Prior middle ear surgeries or trauma including disruption of ossicles

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (13)

• Lehnhardt E. [Placement of intracochlear electrodes with Healon]. HNO. 1992 Mar;40(3):86-9. German.

  PMID: 1577630 BACKGROUND

• Rogowski M, Reiss G, Lehnhardt E. Morphologic study of the guinea pig cochlea after cochlear implantation using the "soft surgery" technique. Ann Otol Rhinol Laryngol Suppl. 1995 Sep;166:434-6.

  PMID: 7668741 BACKGROUND

• Gstoettner W, Hamzavi J, Franz P, Plenk H Jr, Czerny C, Susani M, Adunka O, Baumgartner WD. [Intracochlear position of cochlear implant electrodes]. Wien Klin Wochenschr. 2000 Jun 2;112(11):477-80. German.

  PMID: 10890124 BACKGROUND

• Lenarz T, Stover T, Buechner A, Lesinski-Schiedat A, Patrick J, Pesch J. Hearing conservation surgery using the Hybrid-L electrode. Results from the first clinical trial at the Medical University of Hannover. Audiol Neurootol. 2009;14 Suppl 1:22-31. doi: 10.1159/000206492. Epub 2009 Apr 22.

  PMID: 19390172 BACKGROUND

• Incerti PV, Ching TY, Cowan R. A systematic review of electric-acoustic stimulation: device fitting ranges, outcomes, and clinical fitting practices. Trends Amplif. 2013 Mar;17(1):3-26. doi: 10.1177/1084713813480857.

  PMID: 23539259 BACKGROUND

• Lenarz T, James C, Cuda D, Fitzgerald O'Connor A, Frachet B, Frijns JH, Klenzner T, Laszig R, Manrique M, Marx M, Merkus P, Mylanus EA, Offeciers E, Pesch J, Ramos-Macias A, Robier A, Sterkers O, Uziel A. European multi-centre study of the Nucleus Hybrid L24 cochlear implant. Int J Audiol. 2013 Dec;52(12):838-48. doi: 10.3109/14992027.2013.802032. Epub 2013 Sep 2.

  PMID: 23992489 BACKGROUND

• Aschendorff A, Kromeier J, Klenzner T, Laszig R. Quality control after insertion of the nucleus contour and contour advance electrode in adults. Ear Hear. 2007 Apr;28(2 Suppl):75S-79S. doi: 10.1097/AUD.0b013e318031542e.

  PMID: 17496653 BACKGROUND

• Finley CC, Holden TA, Holden LK, Whiting BR, Chole RA, Neely GJ, Hullar TE, Skinner MW. Role of electrode placement as a contributor to variability in cochlear implant outcomes. Otol Neurotol. 2008 Oct;29(7):920-8. doi: 10.1097/MAO.0b013e318184f492.

  PMID: 18667935 BACKGROUND

• Mandala M, Colletti L, Tonoli G, Colletti V. Electrocochleography during cochlear implantation for hearing preservation. Otolaryngol Head Neck Surg. 2012 May;146(5):774-81. doi: 10.1177/0194599811435895. Epub 2012 Jan 30.

  PMID: 22291043 BACKGROUND

• 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

• 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

• Adunka OF, Gantz BJ, Dunn C, Gurgel RK, Buchman CA. Minimum Reporting Standards for Adult Cochlear Implantation. Otolaryngol Head Neck Surg. 2018 Aug;159(2):215-219. doi: 10.1177/0194599818764329. Epub 2018 Mar 20.

  PMID: 29557283 BACKGROUND

• Harris MS, Koka K, Thompson-Harvey A, Harvey E, Riggs WJ, Saleh S, Holder JT, Dwyer RT, Prentiss SM, Lefler SM, Kozlowski K, Hiss MM, Ortmann AJ, Nelson-Bakkum ER, Buchner A, Salcher R, Harvey SA, Hoffer ME, Bohorquez JE, Alzhrani F, Alshihri R, Almuhawas F, Danner CJ, Friedland DR, Seidman MD, Lenarz T, Telischi FF, Labadie RF, Buchman CA, Adunka OF. Amplitude Parameters Are Predictive of Hearing Preservation in a Randomized Controlled Trial of Intracochlear Electrocochleography During Cochlear Implant Surgery. Otol Neurotol. 2024 Sep 1;45(8):887-894. doi: 10.1097/MAO.0000000000004286. Epub 2024 Jul 25.

  PMID: 39052893 DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participant blinded to condition surgeon aware by necessity data reviewers blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Sample of cochlear implant recipients. Half randomized for observation with ECOchG on, half randomized to ECochG off

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 26, 2018
• Study Start: October 1, 2018
• Primary Completion: July 31, 2025
• Study Completion: December 1, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)