Subjective and Objective Performance With the SONNET2EAS

August 11, 2021 updated by: University of North Carolina, Chapel Hill

Purpose: The purpose of this study is to demonstrate the non-inferiority and new features of an external speech processor for cochlear implant recipients.

Participants: This study seeks to enroll 15 cochlear implant recipients listening to previous technology.

Procedures (methods): Subjects will be programmed and tested with old and new technology.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Candidacy criteria for cochlear implantation include adults with normal-to-moderate low-frequency hearing and severe-to-profound high-frequency sensorineural hearing loss. A cochlear implant system includes two parts: 1) the internal electrode array that is surgically implanted into the cochlea, and 2) the external audio processor that picks up the acoustic signal. The external audio processor sends the converted acoustic signal to the internal device, which is presented as electrical pulses via individual electrodes and interpreted by the brain as sound.

When acoustic hearing in the implanted ear is preserved postoperatively, cochlear implant recipients are fit with an electric-acoustic stimulation (EAS) device. An EAS device combines acoustic and cochlear implant technology into a single device to provide acoustic amplification of the aidable low-frequency hearing region and electric stimulation of the mid-to-high frequency region. Cochlear implant recipients demonstrate a significant improvement when listening with EAS as compared to listening with acoustic or electric stimulation alone on measures of speech understanding and subjective benefit. The benefit is thought to be due to the addition of acoustic low-frequency cues.

The MED-EL SONNETEAS system was approved for commercial use in 2017 for adults (MED-EL, Innsbruck, Austria). Recently, the SONNET2EAS was approved and is currently MED-EL Corporation's newest EAS audio processor. While processing with the SONNET2EAS is currently the similar to that of the SONNETEAS, updated "front-end features", including improved artificial intelligence, are available within the device but have not been approved for commercial use.

Front-end processing occurs in the external audio processor prior to the coding of the signal. This processing is intended to optimize signal perception in variable environments (e.g. complex, noisy listening conditions). Currently, the SONNETEAS and SONNET2EAS have two microphones receiving the incoming signal, which are then manipulated to allow for wind noise reduction (WNR) and directional processing. These features are included within the currently approved "Automatic Sound Management (ASM) 2.0" and primarily seek to improve speech perception in the presence of noise. ASM 3.0 may offer cochlear implant listeners an improvement in speech understanding, specifically in complex or noisy listening situations, and potentially improve ease of listening in a dynamic environment. Listeners of devices with front-end processing demonstrate similar or improved performance than with devices without this technology - dependent on the listening situation.

The aim of the present investigation is to compare objective and subjective outcomes with the new front-end features to the current generation in EAS device users, using a within subject design.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (≥18 years at date of enrollment/initial evaluation)
  • MED-EL Cochlear Implant System recipient
  • Unilateral cochlear implant recipient
  • Unaided threshold of ≤65 decibels (dB) Hearing Level (HL) at 125 Hz in implanted ear
  • Six months or greater of SONNETEAS listening experience
  • Consistent device user, as deemed by research team
  • Minimum of 10 enabled electrodes
  • Consonant Nucleus Consonant (CNC) word score of ≥40% with SONNETEAS processor and contralateral ear plugged/masked
  • Native English speaker (as all materials are written or spoken in English)

Exclusion Criteria:

  • Unaided pure tone average (500, 1000, 2000 Hz) ≤60 dB HL in the contralateral (non-implanted) ear
  • Hearing technology other than a conventional hearing aid in the contralateral ear
  • Unwilling, unable, or geographic limitations to participate in study procedures
  • Unwilling to complete datalogging with the processor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Automatic Sound Management 3.0
Current SONNETEAS listeners, who meet the eligibility criteria, will be tested with their current listening configuration and also fit with a SONNET2EAS, programmed with Automatic Sound Management 3.0 (under the Investigational Device Exemption).
Device: Automatic Sound Management 3.0
The investigational front-end features include those within Automatic Sound Management 3.0 (i.e., Ambient Noise and Transient-Noise Reduction, and Adaptive Intelligence). Automatic Sound Management 3.0 will be accessed in the MAESTRO system software. The investigational front-end features within Automatic Sound Management 3.0 will be programmed in the SONNET2EAS processor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Consonant-Nucleus-Consonant (CNC) Words Scores
Time Frame: Up to 2 months after enrollment
Testing open-set word understanding. Recorded CNC Words lists will be presented to the participant. Resultant score is a percentage of words correct with a range of 0% to 100%. A higher score is better. Scores obtained with the SONNETEAS will be compared to those obtained with the SONNET2EAS, programmed with Automatic Sound Management 3.0.
Up to 2 months after enrollment
Difference in Hearing-in-Noise-Test (HINT) Sentences in Diffuse Noise
Time Frame: Up to 2 months after enrollment
Testing open-set sentence understanding with background noise present. Recorded Hearing-in-Noise-Test (HINT) sentences in diffuse noise will be presented to participant. Resultant score is a percentage of words correct with a range of 0% to 100%. A higher score is better. Scores obtained with the SONNETEAS will be compared to those obtained with the SONNET2EAS, programmed with Automatic Sound Management 3.0.
Up to 2 months after enrollment
Difference in reported device satisfaction on the Audio Processor Satisfaction Questionnaire (APSQ)
Time Frame: Up to 2 months after enrollment
Participants report subjective device satisfaction by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. A higher score is greater subjective satisfaction reported by the participant. Scores obtained with the SONNETEAS will be compared to those obtained with the SONNET2EAS, programmed with Automatic Sound Management 3.0.
Up to 2 months after enrollment
Difference in reported subjective benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ)
Time Frame: Up to 2 months after enrollment
Participants report subjective device benefit when hearing speech in a variety of competing contexts by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. A higher score is greater subjective benefit reported by the participant. Scores obtained with the SONNETEAS will be compared to those obtained with the SONNET2EAS, programmed with Automatic Sound Management 3.0.
Up to 2 months after enrollment
Difference in reported subjective benefit on the Spatial Domain of the Speech, Spatial and Qualities of Hearing (SSQ)
Time Frame: 2 Years
Participants reported subjective device benefit for the directional, distance, and movement components of spatial hearing by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. A higher score is greater subjective benefit reported by the participant. Scores obtained with the SONNETEAS will be compared to those obtained with the SONNET2EAS, programmed with Automatic Sound Management 3.0.
2 Years
Difference in reported subjective benefit on the Qualities Domain of the Speech, Spatial and Qualities of Hearing (SSQ)
Time Frame: Up to 2 months after enrollment
Participants reported subjective device benefit in qualities of hearing (including ease of listening and the naturalness, clarity, and identifiability of different sounds) by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. A higher score is greater subjective benefit reported by the participant. Scores obtained with the SONNETEAS will be compared to those obtained with the SONNET2EAS, programmed with Automatic Sound Management 3.0.
Up to 2 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Consonant-Nucleus-Consonant (CNC) Words Scores between listening with SONNET2EAS and contralateral ear plugged/masked with Artificial Intelligence (AI) Mild and AI Off.
Time Frame: Up to 2 months after enrollment
Testing open-set word understanding. Recorded CNC Words lists will be presented to the participant. Resultant score is a percentage of words correct with a range of 0% to 100%. A higher score is better. Scores obtained with the SONNET2EAS AI Mild will be compared to those obtained with the SONNET2EAS AI Off, programmed with Automatic Sound Management 3.0.
Up to 2 months after enrollment
Difference in Hearing-in-Noise-Test (HINT) sentences in diffuse noise Scores between listening with SONNET2EAS and contralateral ear plugged/masked with Artificial Intelligence (AI) Mild and AI Off.
Time Frame: Up to 2 months after enrollment
Testing open-set sentence understanding with background noise present. Recorded HINT Sentences will be presented to the participant. Resultant score is a percentage of words correct with a range of 0% to 100%. A higher score is better. Scores obtained with the SONNET2EAS AI Mild will be compared to those obtained with the SONNET2EAS AI Off, programmed with Automatic Sound Management 3.0.
Up to 2 months after enrollment
Difference in Consonant-Nucleus-Consonant (CNC) Words Scores between listening with SONNET2EAS and contralateral ear with Artificial Intelligence (AI) Mild and AI Off.
Time Frame: Up to 2 months after enrollment
Testing open-set word understanding. Recorded CNC Words lists will be presented to the participant. Resultant score is a percentage of words correct with a range of 0% to 100%. A higher score is better. Scores obtained with the SONNET2EAS AI Mild will be compared to those obtained with the SONNET2EAS AI Off, programmed with Automatic Sound Management 3.0.
Up to 2 months after enrollment
Difference in Hearing-in-Noise-Test (HINT) sentences in diffuse noise Scores between listening with SONNET2EAS and contralateral ear with Artificial Intelligence (AI) Mild and AI Off.
Time Frame: Up to 2 months after enrollment
Testing open-set sentence understanding with background noise present. Recorded HINT Sentences will be presented to the participant. Resultant score is a percentage of words correct with a range of 0% to 100%. A higher score is better. Scores obtained with the SONNET2EAS AI Mild will be compared to those obtained with the SONNET2EAS AI Off, programmed with Automatic Sound Management 3.0.
Up to 2 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Med-El Corporation

Investigators

  • Principal Investigator: Margaret T Dillon, AuD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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