Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

NCT06734039 | Enrolling By Invitation FDA Device

• 1 other identifier: US2401 MED-EL ABF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.

Conditions

Hearing Loss, Unilateral; Cochlear Implants; Hearing Loss, Sensorineural; Single-Sided Deafness (SSD); Asymmetric Hearing Loss

Keywords

cochlear implant; Single-Sided Deafness

Outcome Measures

Primary Outcomes (2)

• Percent correct on AzBio Sentences in Noise

  The AzBio sentence test, consisting of lists of 20 sentences spoken by male and female talkers, will be tested in noise in three spatial listening conditions with after listening experience with each frequency setting. Listening conditions include co-located presentation of the target and noise, target presented with noise to the implanted ear, and target presented with noise to the opposite acoustic hearing ear. Outcomes will be reported as percent correct (%).

  3 to 7 months

• Cochlear Implant Quality of Life - 35 Profile (CIQoL 35)

  Subjects will complete a 35-item questionnaire with a total score ranging from 0-100% (higher score indicates a higher level of functional ability with a cochlear implant) regarding their subjective listening experience in 6 domains: communication, emotional, entertainment, environment, listening effort, social.

  Enrollment to 7 months

Secondary Outcomes (7)

• Post-operative Audiogram

  Enrollment and 12 months

• Percent Correct on Az Bio Sentences in Noise

  12 months

• Percent Correct on Consonant Nucleus Consonant (CNC) Words

  3 to 12 months

• Subjective feedback questionnaire

  Enrollment to 12 months

• Psychoacoustic Testing of Sound Quality and Preference

  7 months

Study Arms (4)

Default Clinical Frequency Setting

ACTIVE COMPARATOR

The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software

Device: Programming of cochlear implant audio processor frequency settings

Default Anatomy-Based Fitting

ACTIVE COMPARATOR

The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software

Device: Programming of cochlear implant audio processor frequency settings

Experimental Anatomy-Based Fitting 1

EXPERIMENTAL

The audio processor frequency setting will be programmed using experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.

Device: Programming of cochlear implant audio processor frequency settings

Experimental Anatomy-Based Fitting 2

EXPERIMENTAL

The audio processor frequency setting will be programmed with experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.

Device: Programming of cochlear implant audio processor frequency settings

Interventions

Programming of cochlear implant audio processor frequency settings DEVICE

Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software

Also known as: anatomy-based fitting

Default Anatomy-Based Fitting; Default Clinical Frequency Setting; Experimental Anatomy-Based Fitting 1; Experimental Anatomy-Based Fitting 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (6)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MED-EL Corporation

Durham, North Carolina, 27516, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (17)

• Shannon CM, Schvartz-Leyzac KC, Dubno JR, McRackan TR. Determinants of Cochlear Implant Satisfaction and Decisional Regret in Adult Cochlear Implant Users. Otol Neurotol. 2023 Dec 1;44(10):e722-e729. doi: 10.1097/MAO.0000000000004028. Epub 2023 Oct 19.

  PMID: 37853774 BACKGROUND

• Sturm JJ, Ma C, McRackan TR, Schvartz-Leyzac KC. Frequency-to-Place Mismatch Impacts Cochlear Implant Quality of Life, But Not Speech Recognition. Laryngoscope. 2024 Jun;134(6):2898-2905. doi: 10.1002/lary.31264. Epub 2024 Jan 12.

  PMID: 38214299 BACKGROUND

• Kurz A, Herrmann D, Muller-Graff FT, Voelker J, Hackenberg S, Rak K. Anatomy-based fitting improves speech perception in noise for cochlear implant recipients with single-sided deafness. Eur Arch Otorhinolaryngol. 2025 Jan;282(1):467-479. doi: 10.1007/s00405-024-08984-4. Epub 2024 Sep 19.

  PMID: 39299967 BACKGROUND

• Fan X, Yang T, Fan Y, Song W, Gu W, Lu X, Chen Y, Chen X. Hearing outcomes following cochlear implantation with anatomic or default frequency mapping in postlingual deafness adults. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):719-729. doi: 10.1007/s00405-023-08151-1. Epub 2023 Aug 7.

  PMID: 37548704 BACKGROUND

• Kurz A, Herrmann D, Hagen R, Rak K. Using Anatomy-Based Fitting to Reduce Frequency-to-Place Mismatch in Experienced Bilateral Cochlear Implant Users: A Promising Concept. J Pers Med. 2023 Jul 8;13(7):1109. doi: 10.3390/jpm13071109.

  PMID: 37511722 BACKGROUND

• Creff G, Lambert C, Coudert P, Pean V, Laurent S, Godey B. Comparison of Tonotopic and Default Frequency Fitting for Speech Understanding in Noise in New Cochlear Implantees: A Prospective, Randomized, Double-Blind, Cross-Over Study. Ear Hear. 2024 Jan-Feb 01;45(1):35-52. doi: 10.1097/AUD.0000000000001423. Epub 2023 Oct 12.

  PMID: 37823850 BACKGROUND

• 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 BACKGROUND

• Tan CT, Martin B, Svirsky MA. Pitch Matching between Electrical Stimulation of a Cochlear Implant and Acoustic Stimuli Presented to a Contralateral Ear with Residual Hearing. J Am Acad Audiol. 2017 Mar;28(3):187-199. doi: 10.3766/jaaa.15063.

  PMID: 28277210 BACKGROUND

• Svirsky MA, Fitzgerald MB, Sagi E, Glassman EK. Bilateral cochlear implants with large asymmetries in electrode insertion depth: implications for the study of auditory plasticity. Acta Otolaryngol. 2015 Apr;135(4):354-63. doi: 10.3109/00016489.2014.1002052. Epub 2015 Feb 26.

  PMID: 25719506 BACKGROUND

• Mertens G, Van de Heyning P, Vanderveken O, Topsakal V, Van Rompaey V. The smaller the frequency-to-place mismatch the better the hearing outcomes in cochlear implant recipients? Eur Arch Otorhinolaryngol. 2022 Apr;279(4):1875-1883. doi: 10.1007/s00405-021-06899-y. Epub 2021 Jun 15.

  PMID: 34131770 BACKGROUND

• Canfarotta MW, Dillon MT, Buss E, Pillsbury HC, Brown KD, O'Connell BP. Frequency-to-Place Mismatch: Characterizing Variability and the Influence on Speech Perception Outcomes in Cochlear Implant Recipients. Ear Hear. 2020 Sep/Oct;41(5):1349-1361. doi: 10.1097/AUD.0000000000000864.

  PMID: 32205726 BACKGROUND

• Goupell MJ, Noble JH, Phatak SA, Kolberg E, Cleary M, Stakhovskaya OA, Jensen KK, Hoa M, Kim HJ, Bernstein JGW. Computed-Tomography Estimates of Interaural Mismatch in Insertion Depth and Scalar Location in Bilateral Cochlear-Implant Users. Otol Neurotol. 2022 Jul 1;43(6):666-675. doi: 10.1097/MAO.0000000000003538.

  PMID: 35761459 BACKGROUND

• Fitzgerald MB, Prosolovich K, Tan CT, Glassman EK, Svirsky MA. Self-Selection of Frequency Tables with Bilateral Mismatches in an Acoustic Simulation of a Cochlear Implant. J Am Acad Audiol. 2017 May;28(5):385-394. doi: 10.3766/jaaa.15077.

  PMID: 28534729 BACKGROUND

• Fitzgerald MB, Sagi E, Jackson M, Shapiro WH, Roland JT Jr, Waltzman SB, Svirsky MA. Reimplantation of hybrid cochlear implant users with a full-length electrode after loss of residual hearing. Otol Neurotol. 2008 Feb;29(2):168-73. doi: 10.1097/mao.0b013e31815c4875.

  PMID: 18165793 BACKGROUND

• Shannon RV. The relative importance of amplitude, temporal, and spectral cues for cochlear implant processor design. Am J Audiol. 2002 Dec;11(2):124-7. doi: 10.1044/1059-0889(2002/013).

  PMID: 12691223 BACKGROUND

• Fu QJ, Shannon RV. Effects of electrode configuration and frequency allocation on vowel recognition with the Nucleus-22 cochlear implant. Ear Hear. 1999 Aug;20(4):332-44. doi: 10.1097/00003446-199908000-00006.

  PMID: 10466569 BACKGROUND

• Dorman MF, Loizou PC, Rainey D. Simulating the effect of cochlear-implant electrode insertion depth on speech understanding. J Acoust Soc Am. 1997 Nov;102(5 Pt 1):2993-6. doi: 10.1121/1.420354.

  PMID: 9373986 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Unilateral; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katelyn Glassman, AuD

  Med-El Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to each of the frequency settings they are utilizing.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 13, 2024
• Study Start: November 10, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (6)