Subjective and Objective Performance With the SONNET2EAS

NCT04721990 | Withdrawn FDA Device

• 1 other identifier: 20-1857
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss; Hearing Disability

Keywords

Cochlear Implant; Front End Processing; Cochlear Implant Audio Processor

Outcome Measures

Primary Outcomes (6)

• Difference in Consonant-Nucleus-Consonant (CNC) Words Scores

  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

  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)

  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)

  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)

  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)

  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 Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to 2 months after enrollment

Study Arms (1)

Automatic Sound Management 3.0

EXPERIMENTAL

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

Interventions

Automatic Sound Management 3.0 DEVICE

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.

Automatic Sound Management 3.0

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Med-El Corporation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (9)

• Adunka OF, Dillon MT, Adunka MC, King ER, Pillsbury HC, Buchman CA. Hearing preservation and speech perception outcomes with electric-acoustic stimulation after 12 months of listening experience. Laryngoscope. 2013 Oct;123(10):2509-15. doi: 10.1002/lary.23741. Epub 2013 Aug 5.

  PMID: 23918623 BACKGROUND

• Billinger-Finke M, Bracker T, Weber A, Amann E, Anderson I, Batsoulis C. Development and validation of the audio processor satisfaction questionnaire (APSQ) for hearing implant users. Int J Audiol. 2020 May;59(5):392-397. doi: 10.1080/14992027.2019.1697830. Epub 2020 Jan 16.

  PMID: 31944127 BACKGROUND

• Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.

  PMID: 15035561 BACKGROUND

• Gifford RH, Dorman MF. THE PSYCHOPHYSICS OF LOW-FREQUENCY ACOUSTIC HEARING IN ELECTRIC AND ACOUSTIC STIMULATION (EAS) AND BIMODAL PATIENTS. J Hear Sci. 2012 May 1;2(2):33-44.

  PMID: 24244874 BACKGROUND

• Gifford RH, Grantham DW, Sheffield SW, Davis TJ, Dwyer R, Dorman MF. Localization and interaural time difference (ITD) thresholds for cochlear implant recipients with preserved acoustic hearing in the implanted ear. Hear Res. 2014 Jun;312:28-37. doi: 10.1016/j.heares.2014.02.007. Epub 2014 Mar 7.

  PMID: 24607490 BACKGROUND

• Hagen R, Radeloff A, Stark T, Anderson I, Nopp P, Aschbacher E, Moltner A, Khajehnouri Y, Rak K. Microphone directionality and wind noise reduction enhance speech perception in users of the MED-EL SONNET audio processor. Cochlear Implants Int. 2020 Jan;21(1):53-65. doi: 10.1080/14670100.2019.1664529. Epub 2019 Sep 16.

  PMID: 31524107 BACKGROUND

• PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.

  PMID: 14485785 BACKGROUND

• Pillsbury HC 3rd, Dillon MT, Buchman CA, Staecker H, Prentiss SM, Ruckenstein MJ, Bigelow DC, Telischi FF, Martinez DM, Runge CL, Friedland DR, Blevins NH, Larky JB, Alexiades G, Kaylie DM, Roland PS, Miyamoto RT, Backous DD, Warren FM, El-Kashlan HK, Slager HK, Reyes C, Racey AI, Adunka OF. Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. Otol Neurotol. 2018 Mar;39(3):299-305. doi: 10.1097/MAO.0000000000001691.

  PMID: 29342054 BACKGROUND

• Wolfe J, Neumann S, Marsh M, Schafer E, Lianos L, Gilden J, O'Neill L, Arkis P, Menapace C, Nel E, Jones M. Benefits of Adaptive Signal Processing in a Commercially Available Cochlear Implant Sound Processor. Otol Neurotol. 2015 Aug;36(7):1181-90. doi: 10.1097/MAO.0000000000000781.

  PMID: 26049314 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Margaret T Dillon, AuD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)