Place-based Mapping in EAS Listeners

University of North Carolina (UNC)

Status: Completed

Conditions: Cochlear Implant

Treatments: Other: default mapping; Other: place-based mapping

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04722042

20-3022

R21DC018389 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Purpose: Investigate monaural and binaural hearing in electric-acoustic stimulation (EAS) users with place-based versus default maps.

Participants: Cochlear implant recipients and normal-hearing listeners Procedures (methods): This is a prospective, longitudinal investigation of the monaural and binaural outcomes (such as speech perception, spatial hearing, and/or subjective benefit) of cochlear implant recipients listening with different programs. The programs will incorporate different patient and device variables to determine the effect on cochlear implant recipient outcomes.

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Cochlear implant participants

Inclusion Criteria:

• 18-80 years of age at implantation, identify English as native language, Medical Electronics (MED-EL) array recipient, and a postoperative unaided detection threshold of less than or equal to 65 decibel (dB) hearing level (HL) at 125 Hz

Exclusion Criteria:

• Report or present with a cognitive delay or impairment

Normal-hearing controls

Inclusion Criteria:

• 18-80 years of age at time of testing, unaided detection thresholds of 35 dB HL or better from 500-4000 Hz, identify English as native language

Exclusion Criteria:

• Report or present with a cognitive delay or impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 3 patient groups

Cochlear implant participants with Default maps

Other group

Description:

The default frequency filters assigned by the clinical software

Treatment:

Other: default mapping

Cochlear implant participants with Place-Based maps

Experimental group

Description:

Frequency filters adjusted to align with the cochlear place frequency

Treatment:

Other: place-based mapping

Normal hearing controls listening to simulations

Other group

Description:

Normal hearing controls listening to simulations of default and place-based maps.

Treatment:

Other: place-based mapping

Other: default mapping