Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners

Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.

Study Overview

• Status: Recruiting
• Conditions: Deafness
• Intervention / Treatment: Other: Montreal Cognitive Assessment (MoCA); Other: Detection Threshold Testing; Other: Psychophysical Testing; Other: Speech Perception Testing; Other: Telemetry Recordings

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Arenberg; Phone Number: 617-807-7904; Email: julie_arenberg@meei.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Mass Eye and Ear
      • Contact: Julie Arenberg; Phone Number: 617-807-7904; Email: julie_arenberg@meei.harvard.edu
      • Principal Investigator: Julie Arenberg
    • Waltham, Massachusetts, United States, 02453
      • Recruiting
      • Boston Children's Hospital
      • Contact: Amanda Griffin; Phone Number: 781-216-3657; Email: amanda.griffin@childrens.harvard.edu
      • Principal Investigator: Amanda Griffin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria

• Adult at least 18 years old
• Native speakers of American English
• Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

CHILDREN Inclusion Criteria

• Children at least 6 months old
• Native speakers of American English

• Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

  • For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted.

Exclusion Criteria:

Exclusion for all Cochlear Implant Subjects:

• Inability to provide informed consent
• Does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device
• Unable to carry out the study protocol or tasks required in the study

Exclusion for all Normal Hearing Subjects:

• Inability to provide informed consent
• Hearing loss, or significant history of hearing related issues
• Unable to carry out the study protocol or tasks required in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention to assess CI; To develop new programming strategies for individuals that will improve performance for a wider range of cochlear implant people

Other: Montreal Cognitive Assessment (MoCA); Subjects will be asked to complete this one-page cognitive test assesses short-term memory recall and attention. This test takes approximately 10 minutes.; Other: Detection Threshold Testing; Subjects will be asked to listen for the softest sound they can hear ("threshold') with different electrode configurations; Other: Psychophysical Testing; Subjects will be asked to determine the difference between different types of sounds, such as those that vary in pitch and/or volume. Sometimes they will be asked to judge the sound quality of sounds that have very small differences, or make loudness judgments and comparisons.; Other: Speech Perception Testing; Subjects will be asked to listen to words and sentences in quiet and/or in the presence of background noise. For this task they will be asked to repeat the words or sentences following its presentation or use the computer mouse to respond.; Other: Telemetry Recordings; Subjects who wear a cochlear implant, for each cochlear implant channel or pair of channels, measurements will be made from other available electrodes in their implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slopes of the spread of excitation of the electrically evoked compound action potential responses	Responses of the auditory nerve can be measured directly from the cochlear implant using software developed by the implant manufacturer. By changing the distance between two electrodes, we can quantify the spread of activation in the cochlea.	Baseline
Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.	A behavioral test designed to measure how spectral information is processed in the auditory system. By changing the relationship between a masker and target signal, we can assess resolution.	Baseline
Changes in vowel identification scores	Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.	Baseline and weekly for 10 weeks after the intervention
Changes in sentence recognition scores	Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.	Baseline and weekly for 10 weeks after the intervention
Changes in speech-gap detection thresholds	Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing.	Baseline and weekly for 10 weeks after the intervention
Changes in phoneme discrimination scores	Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.	Baseline and weekly for 10 weeks after the intervention
Changes in time (weeks) with programming strategy	Outcome measures will be obtained at weekly intervals during the intervention, and the weekly collection of those measures will be analyzed.	Baseline and weekly for 10 weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	A secondary age analysis on all outcome measures will be applied.	Age at baseline
Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores	The IT-MAIS is a study-team-guided parental report about how infants and toddlers are responding to sound.	Baseline, and weekly for 10 weeks after the intervention
Macarthur-Bates vocabulary inventory scores	This test allows the study team and parents to monitor speech and language development, specifically new word learning.	Baseline, and weekly for 10 weeks after the intervention
Hearing quality of life (HEARQL) scores	The HEAR-QL is a self-assessment test normed for children to assess how they hear in everyday life with different interventions	Baseline, 5 weeks, and 10 weeks after the intervention
Sound quality questionnaire	Participants will be asked to rate sound quality with different interventions in comparison to their everyday listening on a 7-point scale (from minus 3 - much worse, up to plus 3 - much better, 0 is the same)	Baseline and weekly for 10 weeks after the intervention

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborators: Boston Children's Hospital; University of Washington
• Investigators: Principal Investigator: Julie Arenberg, Massachusetts Eye and Ear

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: MGB_2019P000239

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No