A Study to Evaluate the Effectiveness of a Dexamethasone Eluting Slim Modiolar Electrode in the Reduction of Fibrosis in a Newly Implanted Adult Population with Bilateral, Post-Linguistic, Moderate to Profound Sensorineural Hearing Loss

Overview

About this study

The purpose of this study is show the effectiveness of a dexamethasone eluting electrode in an adult population with post-lingual, bilateral, moderate to profound sensorineural hearing loss in the reduction of fibrosis (as measured by impedance) when compared to a conventional, non-dexamethasone eluting electrode and in the improvement of speech recognition from preoperative baseline.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss
at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a
pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.

- 18 years or older at time of consent.

Exclusion Criteria:

- Abnormal cochlear and middle ear anatomy

- History with cochlear implant surgery

- Allergy to dexamethasone

- Women who are pregnant or plan to become pregnant

- Unable/unwilling to comply to study requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/20/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Aniket Saoji, Ph.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Aniket Saoji, Ph.D.

Closed for enrollment

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