Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery

Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes

Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss; Cochlear Implant; Cochlear Microphonics; Electrocochleography
• Intervention / Treatment: Device: Cochlear implantation

Detailed Description

Branches:

• Perimodiolar (PM)
• Lateral wall (PL)

Follow up schedule:

Preoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Federico A Di Lella, MD PhD; Phone Number: 9490 +5411 49590200; Email: federico.dilella@hospitalitaliano.org.ar

Study Locations

• Argentina
  • Buenos Aires
    • Capital federal, Buenos Aires, Argentina, C1199ABB
      • Recruiting
      • Hospital Italiano de Buenos Aires
      • Contact: Federico A Di Lella, MD PhD; Phone Number: 9490 54-11-49590200; Email: federico.dilella@hospitalitaliano.org.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients over 12 months of age who will receive a cochlear implant

Description

Inclusion Criteria:

Patients to receive a Cochlear implant 12 Months of age or older at the time of incorporation Willingness to participate and comply with the requirements of the protocol Residual hearing better than 80 dBA at 500 Hz

Exclusion Criteria:

Medical or pharmacological comorbid condition that contraindicates cochlear implantation.

Previous implantation in the ear of the new implant Ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide Abnormal cochlear / neural anatomy on preoperative CT or MRI (excluding dilated vestibular aqueduct syndrome) Deafness due to lesions of the central auditory pathway. (Exclusion for evaluation of residual hearing) Diagnosis of Auditory Neuropathy Spectrum Disorder (Exclusion for evaluation of residual hearing) Active infection in the middle ear Chronic inflammatory processes in the middle ear Disabilities that could prevent participation in the evaluations Unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol.

Surgical impossibility to follow the guidelines of the minimally traumatic technique.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Perimodiolar (PM); Patients to be implanted with: Mid Scala or CI532 / 632 (Slim modiolar) electrode	Device: Cochlear implantation; Electrode surgically implanted in patient's cochlea to improve hearing
Lateral wall (PL); Patients to be implanted with: Slim J or CI522 / 622 (Slim Lateral) electrode	Device: Cochlear implantation; Electrode surgically implanted in patient's cochlea to improve hearing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude of cochlear microphonics	Postoperative amplitude of cochlear microphonics	0-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cochlear implant impedance	Postoperative value of cochlear implant impedance	0-12 months
Residual hearing	Average audiometric threshold	0-12 months

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Investigators: Principal Investigator: Federico A Di Lella, MD PhD, Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Anticipated): December 19, 2022
• Study Completion (Anticipated): December 19, 2023

Study Registration Dates

• First Submitted: October 3, 2021
• First Submitted That Met QC Criteria: October 3, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 3, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 5906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share IPD to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No