De-escalated Cochlear Implant Programming Paradigm

Overview

About this study

The purpose of this study to compare the effectiveness of a de-escalated paradigm of cochlear implant (CI) programming to the traditional, more frequent, approach to programming and demonstrate non-inferiority based on common audiology speech recognition and quality-of-life scores.

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:

Adult patients (≥ 18 years of age) with a diagnosis of bilateral moderate to profound sensorineural hearing loss who are undergoing unilateral cochlear implantation at Mayo Clinic in Rochester, MN.
Patients must show normal-to-high performance in speech recognition.
Patient must show an improvement in CNC word scores in quiet of 20% or greater from pre-implantation scores by 3 months post-activation in the implanted ear to proceed with the trial.

Exclusion Criteria:

Patients < 18 years of age.
Patients undergoing revision implantation, completion bilateral cochlear implantation, or implantation for unilateral deafness will be excluded from enrollment.
Patients unable to provide consent will be excluded.
No patients will be excluded based on gender or race.

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

Eligibility last updated 11/1/22. 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	Contact
Rochester, Minn. Mayo Clinic principal investigator Matthew Carlson, M.D.	Open for enrollment	Contact information: Nicole Tombers R.N. (507) 293-2445 Tombers.Nicole@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Carlson, M.D.

Open for enrollment

Contact information:

Nicole Tombers R.N.

(507) 293-2445

Tombers.Nicole@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials