Hearing Loss
Conditions
Brief summary
This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.
Interventions
DEVICECochlear Implant
Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
DEVICEModified Implant Procedure
Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* will be undergoing surgery for a cochlear implant from Cochlear Americas * is willing to participate in the study
Exclusion criteria
* has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted * pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AzBio Sentence Recognition Test Score | Up to Year 1 post cochlear implant activation | The AzBio Sentence Recognition Test is a clinical tool used to evaluate a person's ability to understand speech in noisy environments. The total score is the percentage of words correctly understood, ranging from 0-100%. |
Countries
United States
Contacts
CONTACTNicole Capach
CONTACTJ. Thomas Roland, Jr., MD
PRINCIPAL_INVESTIGATORJ. Thomas Roland, Jr., MD
NYU Langone Health
Outcome results
None listed