Clinical trial NCT04721990: Subjective and Objective Performance With the SONNET2EAS
Official title: Subjective and Objective Performance With the SONNET2EAS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss
Hearing Disability
Keywords: Cochlear Implant
Front End Processing
Cochlear Implant Audio Processor
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Med-El Corporation
First posted: 2021-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Consonant-Nucleus-Consonant (CNC) Words Scores
timeFrame: Up to 2 months after enrollment
measure: Difference in Hearing-in-Noise-Test (HINT) Sentences in Diffuse Noise
timeFrame: Up to 2 months after enrollment
measure: Difference in reported device satisfaction on the Audio Processor Satisfaction Questionnaire (APSQ)
timeFrame: Up to 2 months after enrollment
measure: Difference in reported subjective benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ)
timeFrame: Up to 2 months after enrollment
measure: Difference in reported subjective benefit on the Spatial Domain of the Speech, Spatial and Qualities of Hearing (SSQ)
timeFrame: 2 Years
measure: Difference in reported subjective benefit on the Qualities Domain of the Speech, Spatial and Qualities of Hearing (SSQ)
timeFrame: Up to 2 months after enrollment
Secondary outcomes:
measure: 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.
timeFrame: Up to 2 months after enrollment
measure: 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.
timeFrame: Up to 2 months after enrollment
measure: Difference in Consonant-Nucleus-Consonant (CNC) Words Scores between listening with SONNET2EAS and contralateral ear with Artificial Intelligence (AI) Mild and AI Off.
timeFrame: Up to 2 months after enrollment
measure: 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.
timeFrame: Up to 2 months after enrollment
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Margaret T Dillon, AuD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.