Reverberation Effects on MED-EL Recipients

Hearing Loss, Sensorineural Clinical Trial

Official title:

The Effects of Reverberation on Speech Understanding in MED-EL Cochlear Implant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143296
• Other study ID #: 20170198
• Status: Completed
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: April 16, 2021

Study information

• Verified date: August 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.

Description:

The study will determine if electrode length and coding strategy effect performance. The investigator will also study performance over time with new recipients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• MED-EL current cochlear implant recipients of the Flex 24 or 28 will be included

• Minimum of 6 months experience with their cochlear implant

• Minimum of 10 new adult Med-El recipients of the Flex 24 or Flex 28 electrodes

• Patient at the University of Miami

Exclusion Criteria:

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Other:
• Simulated reverberant environment
Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.

Locations

Country	Name	City	State
United States	University of Miami Department of Otolaryngology	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Med-El Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech Performance	Speech performance recorded as percent correct compared to different electrode lengths.	Up to six months
Primary	Coding strategy	Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies.	Two hours