Prospective Study of Round Window Versus Cochleostomy Approach to CI Surgery

Prospective Randomized Controlled Double-blinded Study Comparing Cochlear Implantation Through a Round Window Versus Cochleostomy Approach

To the investigators' knowledge, no clinical study has prospectively investigated the relationship between surgical insertion technique, intracochlear electrode location, and postoperative hearing outcomes. To this end, the investigators are conducting a multicenter prospective randomized controlled double-blinded study comparing round window and cochleostomy cochlear implant electrode insertion.

Study Overview

• Status: Terminated
• Conditions: Deafness
• Intervention / Treatment: Procedure: Cochlear implant surgery

Detailed Description

Cochlear implant procedure has become the standard of care for patients with severe-to-profound sensorineural hearing loss. Successful outcomes are dependent on extrinsic and intrinsic factors. Significant predictive factors for hearing outcomes in patients with CIs have been previously reported. These include, but are not limited to, duration of deafness, level of preimplant speech recognition, pre/postlingual status, and the coupling of device electrodes. Recipient age does not appear to have a significant impact on hearing outcomes in elderly candidates.

A number of recent studies have proposed that intraoperative factors may be important determinants of electrode location and possibly of audiological outcome. Preliminary reports suggest that intracochlear electrode position- specifically, placement within the ST-is associated with improved audiological outcomes. Additionally, different surgical techniques have been proposed to minimize trauma during electrode insertion and to increase the likelihood of placement within the ST - namely round window and anteroinferior cochleostomy electrode insertion.

Currently, the best surgical approach for electrode insertion is highly debated, fueled by a lack of strong evidence to support one method over another. While a number of CI centers have begun to utilize a round window approach, many large volume centers in the United States and world wide continue to routinely employ cochleostomy electrode insertions. With an increasing number of patients being implanted with greater degrees of residual hearing, such data will become critical towards reducing intracochlear injury and optimizing patient outcomes. To the investigators' knowledge, no clinical study has prospectively investigated the relationship between surgical insertion technique, intracochlear electrode location, and postoperative hearing outcomes. To this end, the investigators are initiating a multicenter prospective randomized controlled double-blinded study comparing round window and cochleostomy cochlear implant electrode insertion.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria are:

• 18 years of age or older,
• less than a 10-year duration of deafness in the ear to be implanted,
• primary surgery,
• normal shaped cochleae,
• no retrocochlear pathology, and
• grossly normal cognitive function.

Exclusion criteria are:

• less than 18 years of age,
• prelingual deafness, or
• greater than 10-years duration of deafness in the ear to be implanted;
• prior otologic surgery in the implanted ear (excluding tympanostomy tube placement),
• inner ear malformation present in the ear to be implanted,
• retrocochlear pathology present in the auditory system to be implanted,
• developmental delay or known cognitive impairment, or
• pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: round window; Half of the participants will be randomized to the round window technique of cochlear implant device electrode insertion. Intervention for participants randomized to the round window arm include having the round window technique used for the electrode insertion during the participant's cochlear implant surgery. Participants in this arm of the study will also have a post operative CT scan at about three months after surgery.	Procedure: Cochlear implant surgery; Surgical placement of a cochlear implant device.
Active Comparator: cochleostomy; Half of the participants will be randomized to the cochleostomy technique of cochlear implant device electrode insertion. For the participants randomized to the cochleostomy arm, the surgeon will use a cochleostomy technique for the electrode insertion during the participant's cochlear implant surgery. Participants in this arm of the study will also have a post operative CT scan at about three months after surgery.	Procedure: Cochlear implant surgery; Surgical placement of a cochlear implant device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cochlear implant electrode location after surgery	a standard temporal bone CT scan will be used to show the location of the electrode in the cochlea	about three months post op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant levels of speech perception	standard audiometry speech perception tests will be administered	Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Participant levels of word recognition scores	standard audiometry CNC word score test will be administered	Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Participant levels of sentence recognition scores	standard audiometry AZBio sentence score test will be administered	Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew Carlson, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 12, 2019
• Study Completion (Actual): March 12, 2019

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: cochlear implants; round window; cochleostomy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 15-000576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No