Place-based Mapping in EAS Listeners

NCT ID: NCT04722042

Last Updated: 2025-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2024-07-07

Brief Summary

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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.

Detailed Description

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Conditions

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Cochlear Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized to one of two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participant and testing audiologist were blinded to the randomized map for Arm 1 (cochlear implant users with default maps) and Arm 2 (cochlear implant users with place-based maps). Arm 3 is normal hearing participants listening to simulations of default and place-based maps.

Study Groups

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Cochlear implant participants with Default maps

The default frequency filters assigned by the clinical software

Group Type OTHER

default mapping

Intervention Type OTHER

Default frequency filter assignments

Cochlear implant participants with Place-Based maps

Frequency filters adjusted to align with the cochlear place frequency

Group Type EXPERIMENTAL

place-based mapping

Intervention Type OTHER

Adjusting the electric frequency filters to align with the cochlear place frequency

Normal hearing controls listening to simulations

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

Group Type OTHER

place-based mapping

Intervention Type OTHER

Adjusting the electric frequency filters to align with the cochlear place frequency

default mapping

Intervention Type OTHER

Default frequency filter assignments

Interventions

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place-based mapping

Adjusting the electric frequency filters to align with the cochlear place frequency

Intervention Type OTHER

default mapping

Default frequency filter assignments

Intervention Type OTHER

Eligibility Criteria

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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


* 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

Normal-hearing controls


* Report or present with a cognitive delay or impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret T Dillon, AuD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Kevin D Brown, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UNC ENT at Carolina Crossing

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Dillon MT, Canfarotta MW, Buss E, Rooth MA, Richter ME, Overton AB, Roth NE, Dillon SM, Raymond JH, Young A, Pearson AC, Davis AG, Dedmon MM, Brown KD, O'Connell BP. Influence of Electric Frequency-to-Place Mismatches on the Early Speech Recognition Outcomes for Electric-Acoustic Stimulation Users. Am J Audiol. 2023 Mar;32(1):251-260. doi: 10.1044/2022_AJA-21-00254. Epub 2023 Feb 17.

Reference Type RESULT
PMID: 36800505 (View on PubMed)

Dillon MT, O'Connell BP, Canfarotta MW, Buss E, Hopfinger J. Effect of Place-Based Versus Default Mapping Procedures on Masked Speech Recognition: Simulations of Cochlear Implant Alone and Electric-Acoustic Stimulation. Am J Audiol. 2022 Jun 2;31(2):322-337. doi: 10.1044/2022_AJA-21-00123. Epub 2022 Apr 8.

Reference Type RESULT
PMID: 35394798 (View on PubMed)

Dillon MT, Canfarotta MW, Buss E, Hopfinger J, O'Connell BP. Effectiveness of Place-based Mapping in Electric-Acoustic Stimulation Devices. Otol Neurotol. 2021 Jan;42(1):197-202. doi: 10.1097/MAO.0000000000002965.

Reference Type RESULT
PMID: 33885267 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R21DC018389

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-3022

Identifier Type: -

Identifier Source: org_study_id

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