Place-based Mapping in EAS Listeners

NCT04722042 | Completed Results

• 2 other identifiers: 20-3022R21DC018389
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (3)

• Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time

  Monaural perception (e.g., word recognition in quiet) will be assessed at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

  Up to 12 months post-activation

• Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front)

  Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

  Up to 12 months post-activation

• Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front)

  Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

  Up to 12 months post-activation

Secondary Outcomes (1)

• Perceived Abilities Over Time

  Up to 12 months post-activation

Other Outcomes (3)

• Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing

  All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

• Vowel Recognition for Participants With Normal Hearing

  All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

• Sentence Understanding in Noise for Participants With Normal Hearing

  All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

Study Arms (3)

Cochlear implant participants with Default maps

OTHER

The default frequency filters assigned by the clinical software

Other: default mapping

Cochlear implant participants with Place-Based maps

EXPERIMENTAL

Frequency filters adjusted to align with the cochlear place frequency

Other: place-based mapping

Normal hearing controls listening to simulations

OTHER

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

Other: place-based mapping; Other: default mapping

Interventions

place-based mapping OTHER

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

Cochlear implant participants with Place-Based maps; Normal hearing controls listening to simulations

default mapping OTHER

Default frequency filter assignments

Cochlear implant participants with Default maps; Normal hearing controls listening to simulations

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Report or present with a cognitive delay or impairment
• Normal-hearing controls
• 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
• Report or present with a cognitive delay or impairment

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

UNC ENT at Carolina Crossing

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (3)

• 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.

  PMID: 36800505 RESULT

• 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.

  PMID: 35394798 RESULT

• 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.

  PMID: 33885267 RESULT

Results Point of Contact

• Title: Margaret Dillon, AuD, PhD
• Organization: University of North Carolina at Chapel Hill

mdillon@med.unc.edu

919-966-5251

Study Officials

• Margaret T Dillon, AuD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Kevin D Brown, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to one of two groups.

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: February 23, 2021
• Primary Completion: July 7, 2024
• Study Completion: July 7, 2024
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 to 36 months following publication
• Access Criteria: Investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)