Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Hearing Loss, Sensorineural Clinical Trial

Official title:

Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031678
• Other study ID #: P000025/PAS001
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2020
• Source: Med-El Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Electric-Acoustic Stimulation (EAS) Cochlear Implant System
Combination of a cochlear implant and a hearing aid

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Kansas University Medical Center	Kansas City	Kansas
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Stanford Unversity	Palo Alto	California
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Med-El Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Words Correct As Assessed by CUNY Sentence Test.	Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.	Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Secondary	Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.	The HEARRING Scale was developed by the HEARRING Research Group, a collaboration of surgeons and audiologists in the hearing implant field who work together to develop consensus statements. The Scale was published in 2013 by Skarzynski et al. as means to classify post-operative residual hearing thresholds. Residual hearing is classified as complete (100-76%), partial (26-75%), minimal (1-25%), or none (0%) according to an equation which takes into account pre-operative thresholds, post-operative thresholds, and the limits of the audiometer.	Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Secondary	Percentage of Words Correct as Assessed by CNC Words in Quiet.	Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in quiet with CNC words completed through five years post-implantation.	Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Secondary	Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.	The APHAB Questionnaire measures percentage of listening difficulty on a scale from 100% (very difficult) to 0% (not difficult at all). Results are reported as the average listening difficulty across subjects.	Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial