Fundamental Asynchronous Stimulus Timing Sound Coding Study

NCT02698787 | Completed Results DMC

• 1 other identifier: CAM5621
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients.

Conditions

Sensorineural Hearing Loss

Keywords

cochlear implant, sensorineural hearing loss

Outcome Measures

Primary Outcomes (2)

• Change in Open Set Monosyllabic Word Recognition Score

  Open Set Monosyllabic Word Recognition is a test of 50 words each consisting of 3 individual speech sounds. The subject repeats the word s/he hears to the audiologist. The score is based on the percentage of words correct. The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for word recognition in quiet with percentage of words correct.

  Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months)

• Change in Signal-to-Noise Ratio (SRT)

  The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for BKB sentences in noise with mean signal-to-noise ratio (SRT) where participants could understand 50% of sentences in noise using ACE and FAST. Lower SRT values indicate better performance. SRT measures are obtained using two types of background noise. One is "Speech-Shaped Noise" which is white noise or tones made to mimic speech. The other is "Four-Talker Noise" which is multiple talkers made to mimic background conversation.

  Visit 5 (3 Months) and Visit 8 (6 months)

Study Arms (2)

Group 1

EXPERIMENTAL

All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy.

Device: Experimental sound coding strategy (FAST); Device: Commercially available ACE sound coding strategy

Group 2

EXPERIMENTAL

All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation.

Device: Experimental sound coding strategy (FAST); Device: Commercially available ACE sound coding strategy

Interventions

Experimental sound coding strategy (FAST) DEVICE

Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy

Group 1; Group 2

Commercially available ACE sound coding strategy DEVICE

Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Medical and audiological candidate for a unilateral CI24RE, CI512 or CI532 series implant
• Post-linguistically deafened
• Native speaker of American English
• Eighteen years of age or older

You may not qualify if:

• Previous or existing cochlear-implant recipient
• Pre-linguistically deafened (onset of hearing loss at less than two years of age)
• Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
• Diagnosis of retro-cochlear pathology
• Diagnosis of auditory neuropathy
• Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
• Unwillingness or inability to comply with all investigational requirements
• Additional cognitive handicaps that would delay rate of improvement with the cochlear implant

Sponsors & Collaborators

• Cochlear: lead

Study Sites (1)

University of Colorado Health

Aurora, Colorado, 80045, United States

Location

Related Publications (5)

• Daneman , M., & Carpenter, P.A. (1980). Individual differences in working memory and reading. Journal of Verbal Learning andVerbal Behavior, 19, 450-466.

  BACKGROUND

• Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: the SSQ12. Int J Audiol. 2013 Jun;52(6):409-12. doi: 10.3109/14992027.2013.781278.

  PMID: 23651462 BACKGROUND

• Bench J, Kowal A, Bamford J. The BKB (Bamford-Kowal-Bench) sentence lists for partially-hearing children. Br J Audiol. 1979 Aug;13(3):108-12. doi: 10.3109/03005367909078884.

  PMID: 486816 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

• Smith, Z. M. (2010). Improved sensitivity to interaural time differences with the FAST coding strategy. Presented at the 11th International Conference on Cochlear Implants and Other Implantable Auditory Technologies, Stockholm, Sweden.

  BACKGROUND

MeSH Terms

Conditions

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

Results Point of Contact

• Title: Naomi Croghan
• Organization: Cochlear

ncroghan@cochlear.com

+13032642131

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: March 4, 2016
• Study Start: December 1, 2015
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Locations

US (1)