Cochlear ImplantNCT04722042

Place-based Mapping in EAS Listeners

A study testing place-based mapping and default mapping in people with Cochlear Implant, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Cochlear Implant
What is being tested?: place-based mapping and default mapping
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 23 Feb 2021to 7 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UNC ENT at Carolina Crossing
Chapel Hill, North Carolina, 27517

Other trials in United States

About this study

Official title: Place-based Mapping in Electric-acoustic Stimulation Listeners

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
Being tested: place-based mapping, default mapping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

place-based mappingOther
Adjusting the electric frequency filters to align with the cochlear place frequency
default mappingOther
Default frequency filter assignments

Study groups in NCT04722042
Study group	Role	What they receive
Cochlear implant participants with Default maps	Other	The default frequency filters assigned by the clinical software Receives: Other: default mapping
Cochlear implant participants with Place-Based maps	Experimental	Frequency filters adjusted to align with the cochlear place frequency Receives: Other: place-based mapping
Normal hearing controls listening to simulations	Other	Normal hearing controls listening to simulations of default and place-based maps. Receives: Other: place-based mapping; Other: default mapping

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: Up to 12 months post-activation

Secondary outcomes (1)

Perceived Abilities Over Time
Perceived abilities will be assessed with questionnaires (e.g., Speech, Spatial, and Qualities of hearing scale; SSQ) at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). A subject indicates his/her perceived abilities for each question on the SSQ using a Likert scale, with a range of 0-10 (with 10 indicating better perceived abilities). Responses will be compared 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).
Measured: Up to 12 months post-activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 20217 Jul 2024

First posted25 Jan 2021
Study start23 Feb 2021
Primary completion7 Jul 2024
Study completion7 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cochlear ImplantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be randomized to one of two groups.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04722042
Sponsor's protocol ID: 20-3022
Other IDs: R21DC018389
Status last verified: Jul 2024
First submitted: 19 Jan 2021
Last updated: 18 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

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.
PubMed 36800505
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.
PubMed 35394798
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.
PubMed 33885267

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cochlear Implant trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Place-based Mapping in Electric-acoustic Stimulation Listeners
ClinicalTrials.gov ID: NCT04722042
Acronym / sponsor ID: 20-3022
Conditions: Cochlear Implant
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Study start: 23 Feb 2021 (actual)
Primary completion: 7 Jul 2024 (actual)
Study completion: 7 Jul 2024 (actual)
First posted: 25 Jan 2021 (actual)
Results: Posted 18 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: Subjects will be randomized to one of two groups.

Arm	Type	Receives
Cochlear implant participants with Default maps	Other	Other: default mappingThe default frequency filters assigned by the clinical software
Cochlear implant participants with Place-Based maps	Experimental	Other: place-based mappingFrequency filters adjusted to align with the cochlear place frequency
Normal hearing controls listening to simulations	Other	Other: place-based mapping, Other: default mappingNormal hearing controls listening to simulations of default and place-based maps.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
place-based mappingAdjusting the electric frequency filters to align with the cochlear place frequency	Other	Cochlear implant participants with Place-Based maps, Normal hearing controls listening to simulations
default mappingDefault frequency filter assignments	Other	Cochlear implant participants with Default maps, Normal hearing controls listening to simulations

Primary outcome

Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time
Time frame: Up to 12 months post-activation
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).
Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front)
Time frame: Up to 12 months post-activation
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).
Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front)
Time frame: Up to 12 months post-activation
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).

1 secondary outcome

Perceived Abilities Over Time
Time frame: Up to 12 months post-activation

Results and safety

Results posted to the registry on 18 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Default	13	11
Place-based	11	10
Normal Hearing Control	15	15

Primary outcome: Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time

Time frame: Up to 12 months post-activation. Mean (Standard Deviation). Unit: percent of words correctly repeated

Measure	Default n = 11	Place-based n = 10
activation	18 (16)	10 (14)
1 month	40 (23)	34 (22)
3 months	49 (20)	45 (16)
6 months	53 (22)	50 (19)
12 months	56 (26)	54 (15)

Default vs Place-based: p = 0.557, ANOVA

Population analysed: This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

Primary outcome: Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front)

Time frame: Up to 12 months post-activation. Mean (Standard Deviation). Unit: percent of words correctly repeated

Measure	Default n = 11	Place-based n = 10
1 month	10 (21)	19 (23)
3 month	20 (19)	24 (17)
6 month	10 (19)	20 (24)
12 month	18 (21)	28 (14)

Default vs Place-based: p = 0.208, ANOVA

Population analysed: This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

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

Time frame: Up to 12 months post-activation. Mean (Standard Deviation). Unit: percent of words correctly repeated

Measure	Default n = 11	Place-based n = 10
1 month	6 (14)	0 (11)
3 month	15 (11)	10 (14)
6 month	14 (14)	5 (14)
12 month	16 (16)	17 (18)

Default vs Place-based: p = 0.126, ANOVA

Population analysed: This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year from cochlear implant activation for participants in Arms 1 and 2. Participants in Arms 1 and 2 were cochlear implant recipients who were followed for 1 year after cochlear implant activation. Single visit (baseline) for participants in Arm 3. Participants in Arm 3 had normal hearing and listened to simulations of default and place-based maps during one visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cochlear Implant Users With Default Maps	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Cochlear Implant Users With Place-based Maps	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Normal Hearing Controls	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36800505Dillon 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.
Results publication: PubMed 35394798Dillon 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.
Results publication: PubMed 33885267Dillon 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.
Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Related trials for Cochlear Implant

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margaret T Dillon, AuD, PhD principal investigator

University of North Carolina, Chapel Hill

Kevin D Brown, MD, PhD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing place-based mapping and default mapping in people with Cochlear Implant, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time (time frame: Up to 12 months post-activation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04722042, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.