Clinical trial NCT03031678: Electric-Acoustic Stimulation Extended Follow-up Post Approval Study
Official title: Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.

Detailed description: The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at the time of implantation
* Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
* Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
* CNC word recognition score less than or equal to 60% in the ear to be implanted
* CNC word recognition score less than or equal to 60% in the contralateral ear
* English spoken as the primary language

Exclusion Criteria:

* Conductive, retrocochlear, or central auditory disorder
* Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
* Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
* Developmental delays or organic brain dysfunction
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
* Unwillingness or inability of the candidate to comply with all investigational requirements

Primary outcomes:
measure: Percentage of Words Correct As Assessed by CUNY Sentence Test.
timeFrame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Secondary outcomes:
measure: Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.
timeFrame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
measure: Percentage of Words Correct as Assessed by CNC Words in Quiet.
timeFrame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
measure: Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.
timeFrame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Unversity
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Kansas City
country: United States
facility: University of Kansas University Medical Center
state: Kansas
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Skarzynski H, van de Heyning P, Agrawal S, Arauz SL, Atlas M, Baumgartner W, Caversaccio M, de Bodt M, Gavilan J, Godey B, Green K, Gstoettner W, Hagen R, Han DM, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Levevre F, Li Y, Manikoth M, Martin J, Mlynski R, Mueller J, O'Driscoll M, Parnes L, Prentiss S, Pulibalathingal S, Raine CH, Rajan G, Rajeswaran R, Rivas JA, Rivas A, Skarzynski PH, Sprinzl G, Staecker H, Stephan K, Usami S, Yanov Y, Zernotti ME, Zimmermann K, Lorens A, Mertens G. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;(564):3-13. doi: 10.3109/00016489.2013.869059.