CClinicalTrials.gg
CompletedNCT02638883Updated Sep 27, 2022Results posted

Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults

An interventional study of Hybrid SRW cochlear implant in Sensorineural Hearing Loss, sponsored by Cochlear. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-27.

Sponsored by Cochlear · Interventional and Treatment

Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.

Read the detailed description

The Food and Drug Administration recently approved the Cochlear Nucleus Hybrid L24 Implant System (P130016) for individuals aged 18 years and older who present with bilateral residual low frequency hearing sensitivity and severe to profound high frequency sensorineural hearing loss with limited benefit from appropriately fitted bilateral amplification. Additionally, the Nucleus Hybrid S12 Implant has been under evaluation since 2007 (IDE G#070016). The Nucleus Hybrid S-RW is a modification of the current Hybrid S12 implant. The Hybrid S-RW is designed to support implantation via a round window (RW) approach while maintaining the same relative insertion depth as the previous Hybrid S12 when implanted via cochleostomy

02

Conditions studied

  • Sensorineural Hearing Loss

Keywords

  • Adults; high frequency SNHL
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 6 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Cochlear is the lead sponsor of 91 studies on the registry; 11 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Eighteen years of age or older at the time of implantation
  2. Sensorineural hearing loss with the following requirements: a pure tone threshold less (better) than or equal to 60 dB HL at 500 Hz,less than (better) or equal to 80 dB HL at 1500 Hz, and high frequency severe to profound (a threshold average of 2000, 3000, \& 4000 Hz) of > 60dB HL.
  3. Minimum of 30 days experience with appropriately fit bilateral amplification, fit as described in the Fitting and Use of Hearing Aids section below
  4. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) between 20% and 60%, inclusive (i.e., 20% score 60%), in the ear to be implanted
  5. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%
  6. Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through 12-months post-activation

Exclusion criteria

Exclusion Criteria:

  1. Individuals aged greater than 75 years
  2. Duration of severe to profound hearing loss (above 2kHz) greater than 20 years
  3. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
  4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  5. Conductive overlay of 15 dB or greater at two or more frequencies, in the range 500 to 1000 Hz
  6. Deafness due to lesions of the acoustic nerve or central auditory pathway
  7. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease
  8. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
  9. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
  10. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.
05

Study design

Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Implanted

    Subjects will be implanted with the Hybrid SRW cochlear implant.

    Device: Hybrid SRW cochlear implant

Interventions

  • DeviceHybrid SRW cochlear implant

    Subjects will be implanted with the Hybrid SRW

06

What researchers measure

Primary outcomes

  1. CNC (Consonant-nucleus-consonant) Words

    Two CNC( consonant-nucleus-consonant) Word lists (Peterson \& Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome.

    Time frame: 12 months

07

Results

Posted Sep 27, 2022

Participant flow

Participant flow — Overall Study
MilestoneImplanted
Started6
Completed6
Not completed0

Outcome measures

PrimaryCNC (Consonant-nucleus-consonant) Words

Two CNC( consonant-nucleus-consonant) Word lists (Peterson \& Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome.

Time frame:
12 months
Reported as:
Mean · percentage of correct words.
CNC (Consonant-nucleus-consonant) Words
percentage of correct words.Implanted
CNC (Consonant-nucleus-consonant) Words64.8 ± 23.0

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Implanted0/6 (0%)0/6 (0%)4/6 (66.7%)
Most frequent other events
Most frequent other events
EventImplanted
Sudden hearing threshold shift resulting in profound hearing lossEar and labyrinth disorders1/6
Significant decrease in hearing thresholds (20-35dB)Ear and labyrinth disorders1/6
Skin Flap sorenessSkin and subcutaneous tissue disorders1/6
Open circuit electrodesProduct Issues1/6
bronchitisRespiratory, thoracic and mediastinal disorders1/6
Increased tinnitusEar and labyrinth disorders1/6
external otitisEar and labyrinth disorders1/6

Baseline characteristics

Age, Customized
Age, Customized(Participants)Implanted
Count of participants6
Sex: Female, Male
Sex: Female, Male(Participants)Implanted
Female3
Male3
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Implanted
Region of Enrollment
Region of Enrollment(participants)Implanted
United States6
Age at Implant in Years
Age at Implant in Years(years)Implanted
Mean57.5 ± 11.0
Duration of Hearing Loss
Duration of Hearing Loss(years)Implanted
Mean37.8 ± 25.2
08

Study locations

1 site
  • University of Iowa
    Des Moines, Iowa 52242, United States
09

References and documents

Publications

  • 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. PubMed 15035561 ↗
  • 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. PubMed 23651462 ↗
  • 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. PubMed 14485785 ↗
  • Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549. PubMed 21829134 ↗

Study documents

  • Study protocol · May 25, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02638883
Lead sponsor
Cochlear
Collaborators
University of Iowa
Responsible party
Sponsor
First posted
Dec 23, 2015
Start date
Feb 8, 2016
Primary completion
Jun 12, 2019
Completion
Jun 12, 2019
Results posted
Sep 27, 2022
Last update
Sep 27, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion