Ear Center: Hearing Implants

About Active Hearing Implants

Recent advances in cutting edge technology now permits our surgeons to offer hearing improvement for many patients whose hearing could never be helped surgically only a decade ago. Our new hearing technology is comprised of various types of "Active Implantable Hearing Devices." Each type of new implantable hearing device has specific indications for specific types of hearing impairment. Over the last decade, active implantable devices have sorted out into identifiable categories:

Cochlear Implants (Cochlear Am., ABC, Med-EL) [adults and children > 1 year]
Hybrid Cochlear Implants (Cochlear Americas) [adults 18 yrs or older]
Osseointegrated Implants (BAHA, Ponto) [adults and children > 5 years]
Semi-implantable Hearing Devices (Maxum & SoundBridge) [adults >18 yrs]
Totally Implantable Hearing Devices (ESTEEM) [adults > 18 years]

 

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Cochlear Implants

Standard Full Length Insertion Cochlear Implants

  • Cochlear implants by Advanced Bionics, Cochlear Americas, Med-EL
  • Semi -implantable devices for severe-to-profound hearing loss with less than 40% understanding ability
  • External processor & battery or rechargeable power supply (ear level type, single-unit type (Rondo) or body worn processor)
  • Approved by most third party payers and Medicare (except the hybrid devices)
  • Many patients are now being recommended for cochlear implants to be implanted into both ears (binaural implants), either the same day (simultaneous) or staged on different days (synchronous)
  • Advanced Bionics, Cochlear Americas & Med-EL cochlear implants are being implanted at The Ear Center.
  • Med-EL's Synchrony CI is conditionally MRI safe at 1.5 to 3.0 Tesla
  • Dr. Kraus has been implanting cochlear implants in Greensboro since 1986

Hybrid Electro-Acoustic Cochlear Implants (EAC)

  • Hybrid cochlear implants (the Cochlear Americas "Cochlear Nucleus Hybrid Implant System" has been cleared by the FDA) consisting of acoustic stimulation (conventional hearing aid) combined with simultaneous intra-cochlear electrical stimulation (cochlear implant).
  • The concept is to:
    • (1) stimulate intact, residual low frequency hearing with a conventional acoustic signal provided by the hearing aid component of the system and to
    • (2) stimulate high frequency residual spiral ganglion cells with direct electrical stimulation from intra-cochlear electrodes provided by the cochlear implant component.
  • Semi -implantable devices for mild-to-profound hearing loss characterized as steeply sloping high frequency hearing loss and intact low frequency hearing
  • Short (Cochlear Hybrid inserted through the round window or a separate cochleostomy) and long (Med-EL Hybrid, investigational, inserted through the round window) insertion electrodes
  • External sound processor providing simultaneous acoustic and electrical stimulation
  • Rechargeable power supply (ear level BTE type processor)
  • Current research results (as of January 2010) reveal that approximately 25-30% of patients are losing approximately 30% of their residual hearing, usually in a delayed fashion. However, 70% of patients do not lose their residual hearing.
  • The Hybrid L24 is intended for use in one ear by patients aged 18 years or older who obtain limited benefit from appropriately fit hearing aids in both ears and meet the following criteria:
    • Typical preoperative hearing of candidates ranges from normal to moderate hearing loss in the low frequencies, with severe to profound loss in the mid to high frequencies.
    • The consonant nucleus consonant (CNC) word recognition score will be between 10% and 60%, inclusively, in the ear to be implanted in the preoperative aided condition, and in the other ear will be equal to or better than that of the ear to be implanted, but not more than 80% correct.
    • Previously have undergone a suitable hearing aid trial, unless already appropriately fit with hearing aids.
    • Patients wear the Nucleus 6 Processor integrated with the Hybrid Hearing option and Custom Sound programming software.
    • *In the USA, the US FDA has approved the Hybrid L24 Implant for up to a 1.5 Tesla MRI with the magnet in place provided that a proper wrapping technique is used. The best MRI images are obtained by removing the magnet. Magnet removal reduces image artifact by 60-70% around the implant site.

cochlear_hybrid

*Cochlear Nucleus Hybrid L24

 

To learn more about Cochlear America hybrid called the "Cochlear Nucleus Hybrid Implant System", visit the Hybrid Hearing Website at www.Cochlear.com/US/HybridHearing.

 

Osseointegrated Implants

BAHA 4 Hearing Implant by Cochlear Americas

  • Two options:
    • The BAHA4 Connect with a titanium fixture (BAHA 4, BAHA4 Connect) with percutaneous abutment implanted into the skull behind the ear(s) and
    • The BAHA4 Attract with a transcutaneous system using a titanium fixture and plate implanted subcutaneously and a magnetic coupling of the BAHA4 external sound processor.
  • External, wearable, digital BAHA 4 processors attach to the abutment (Connect version) or to a magnet that couples with the external magnet and BAHA4 processor (Attract version).
  • The BAHA4 Sound Processor is 3x faster and has 8x the memory as compared to the BAHA3 Sound Processor
  • Audiologist adjustable (BP100 and BP-110 Power programmable)
  • The BAHA4 has 2.4 GHz wireless and remote capabilities
  • FDA approved for monaural and binaural conductive hearing losses, congenital atresia, with cochlear reserve 45 dB or better
  • FDA approved for single-sided deafness
  • Approved by Medicare, Blue Cross Blue Shield of North Carolina, and the North Carolina State Employees' Health Plan
  • BAHA processors have standard and extended warranty options available
  • BAHA implants are being implanted at The Ear Center - click here

Ponto Hearing Implant by Oticon

  • An alternative to the BAHA style osseointegrated implant
  • Ergonomic sound processor design with angled microphone ports

Ponto Features:

  • Adjustable abutment angle to improve directionality
  • Ponto countersink with stop to improve safety during implantation, countersinking is limited to 0.3mm.
  • Ponto dermatome
  • Ponto soft band - can be used for bilateral use, easily adjustable, six colors, built-in safety release, latex/Velcro free design
  • Ponto sound processor has an outward facing, large program button that is easily accessible and easy to use
  • Ponto sound processor has a "surround" coupler, rather than a "snap" coupler, for ease of coupling to the abutment
  • 10 kHz bandwidth sound processor with 15-channel processing and 10-band frequency response flexibility
  • Dedicated fitting modes using the Genie Medical fitting software for conductive losses versus single-sided deafness
  • Ponto sound processor features include:
    • Automatic Wind Noise Reduction
    • Manual Multiband Adaptive Directionality
    • Wind Noise Reduction
    • Output AGC
    • Up to 4 programs
    • Volume Control
    • Start-up Delay
    • Mute/Stand-by Function
    • Low Battery Warning
    • Telecoil/DAI/FM input
    • Fitting software, Genie Medical
    • Available as right and left models
    • Available in 3 colors (Chroma Beige, Mocca Brown, Diamond Black)
  • Ponto Pro sound processor has the same features as the Ponto with the addition of:
    • Automatic Multiband Adaptive Directionality
    • Tri-State Noise Management
    • Data Logging
    • Learning Volume Control
  • Click here to learn more about the Ponto hearing implant.

Semi-implantable Hearing Devices

MAXUM Hearing Implant

  • Manufactured by Ototronix®, LLC, Houston, TX
  • Based on original SoundTec™ technology and FDA cleared
  • Implantable middle ear magnet (one or both ears)
  • Requires preoperative ear canal mold for the creation of a custom fit, in-the-ear sound processor
  • 1 - 1.5 hour surgical procedure under local anesthesia as an outpatient
  • Externally worn, custom fit, digital, electromagnetic sound processor
  • Increased gain (+60 dB) and wide bandwidth
  • No acoustic feedback

Click here to visit our MAXUM web page for more information.

Click here to visit the Ototronix web site at www.ototronix.com.

Click here to download a copy of our Screening Medical History Questionnaire for the Maxum Hearing Implant

Vibrant SoundBridge™

  • Vibrant SoundBridge™ = floating mass transducer attached to incus or round window membrane
  • External processor with power supply, internal hardware
  • The Vibrant SoundBridge is not currently being implanted at The Ear Center.

Totally Implantable Active Middle Ear Devices

Envoy ESTEEM®

  • Envoy ESTEEM® Totally implantable hearing device was approved by the FDA in 2010 and in Europe, CE mark, in the Summer of 2006)
  • Totally implanted components (Sound Processor + two piezoelectric transducers, a Sensor and a Driver)
  • 4.5 - 9 year, non-rechargeable battery life prior to needing to be replaced.
  • No externally worn components
  • Personal Programmer remote controlled
  • For moderate-to-severe sensorineural hearing loss with 40% or better discrimination (word recognition scores)
  • Esteem battery replacements are being performed at The Ear Center

Otologic Carina™ (currently an investigational device not approved by the FDA)

  • Electro-mechanical device manufactured by Otologics
  • An investigational device undergoing clinical trials in the U.S.
  • Electro-mechanical transducer interfacing with the incus or (second hearing bone)
  • Post-auricular, subcutaneous microphone
  • Rechargeable battery requiring frequent recharging
  • The Carina is an investigational device and is not currently being implanted at The Ear Center.
  • The Carina is no longer being produced by Otologics.

References

1. Tysome JR, Moorthy R, etal. Systematic review of middle ear implants: do they improve hearing as much as conventional hearing aids? Otol Neurotol 2010:31(December):1369-1375

2. Kraus EM, Shohet JA, Catalano PJ. Hearing Results with the ESTEEM Totally Implantable Middle Ear Device: Phase II Trial-1Year Results. Otol Head Neck Surgery 2011;145(1):100-109.

3. Shohet, JA, Kraus EM, Catalano PJ. Profound High-Frequency Sensorineural Hearing Loss Treatment with a Totally Implantable Hearing System. Otology Neurotol 2011;32:1428-1431.

4. Kahue CN, Carlson ML, et al. Middle Ear Implants for Rehabilitation of Sensorineural Hearing Loss: a systematic review of FDA approved devices. Otol Neurotol 2014; March 17: epub ahead of print.

If you would like to learn more about active implantable hearing devices, please contact our office at (336) 273-9932 and ask for our Audiology Department.

Last revised November 8, 2015