Market Overview

MED-EL USA Obtains FDA De Novo Clearance for BONEBRIDGE™ Bone Conduction Implant System


World's first active bone conduction implant coming to the U.S.
market in 2018

MED-EL USA announced today that the U.S. Food and Drug Administration
(FDA) has granted de novo clearance for the BONEBRIDGE
bone conduction hearing implant system for individuals 12 years and
older who have been diagnosed with conductive hearing loss, mixed
hearing loss, or single-sided deafness. Since its introduction in Europe
in 2012, BONEBRIDGE remains the world's first and only active bone
conduction hearing implant, and is widely considered a breakthrough in
bone conduction technology.

This press release features multimedia. View the full release here:

BONEBRIDGE Bone Conduction Hearing Implant System from MED-EL USA (Photo: Business Wire)

BONEBRIDGE Bone Conduction Hearing Implant System from MED-EL USA (Photo: Business Wire)

BONEBRIDGE consists of two components: the internal BCI 601 implant, and
the sleek, award-winning SAMBA audio processor, which can be worn
discretely beneath the hair.

Unlike bone anchored hearing aids with an abutment that protrudes
through the skin and requires lifelong medical treatment and
maintenance, BONEBRIDGE offers intact skin technology. As the implant is
placed completely underneath the skin and the audio processor places
minimal pressure on the skin, BONEBRIDGE recipients enjoy a low
complication rate.

Sound in the environment is captured by BONEBRIDGE's audio processor,
the SAMBA, and is converted into signals which are transferred through
the skin to the implant. The implant converts the signal into mechanical
vibrations that are transferred directly to the bone of the skull. The
bone then conducts these vibrations to the inner ear where they are
interpreted as sound, converted into nerve signals and transmitted to
the auditory nerve. This process bypasses the non-functioning outer and
middle ear, where conductive or mixed hearing loss occurs.

The SAMBA audio processor is equipped with adaptive directional
microphones that automatically identify and minimize noise interference.
This feature is particularly helpful in situations where there is loud
background noise, such as in a restaurant. The Speech Tracking feature
enables SAMBA to automatically recognize the direction from which speech
is coming and makes the corresponding adjustment to the directionality
of the microphone. With the SAMBA remote control, recipients can select
one of five programs, each with its own individual settings, for
particular situations such as a noisy environment or for television and
music. SAMBA processors may be individualized with more than 20
interchangeable color and design covers.

"MED-EL USA is pleased to expand our cutting-edge line of implantable
hearing devices to include BONEBRIDGE for conductive hearing loss, mixed
hearing loss and single-sided deafness," said Raymond Gamble, CEO &
President, MED-EL North America. "Like all of our hearing implants,
BONEBRIDGE is engineered to be future-ready, meaning that recipients
will always be able to benefit from the latest external processing
technology. We welcome those to the MED-EL family who have lived with
these types of hearing loss because they have not wanted to pursue the
limited surgical options currently on the market."

MED-EL USA anticipates that BONEBRIDGE will be available in 2018. For
more information about the BONEBRIDGE system, visit,
or call (888) MED-EL-CI (633-3524).

About Conductive/Mixed Hearing Loss and Single-Sided Deafness

Conductive hearing loss is caused by problems with the ear canal, ear
drum, or middle ear and its tiny bones (the malleus, incus, and stapes).
Causes of conductive hearing loss include congenital absence of the ear
canal or failure of the ear canal to be open at birth, and congenital
absence, malformation, or dysfunction of the middle ear structures.
Conductive hearing loss can also be caused by infection, tumors, middle
ear fluid from infection or Eustachian tube dysfunction, a foreign body,
trauma (as in a skull fracture), and otosclerosis.1 Mixed
hearing loss is a combination of a sensorineural and conductive hearing
loss. It results from problems in both the inner and outer or middle
ear. Single-sided deafness (SSD) is a condition of profound unilateral
sensorineural hearing loss, with normal hearing in the better hearing
ear. SSD is a severe impairment that makes it hard to understand speech
and sounds especially in noisy environments, as well as causes
difficulties in determining the direction of a sound's location.

About MED-EL

MED-EL Medical Electronics, a leader in implantable hearing solutions,
is driven by a mission to overcome hearing loss as a barrier to
communication. The Austrian-based, privately owned business was
co-founded by industry pioneers Ingeborg and Erwin Hochmair, whose
ground-breaking research led to the development of the world's first
micro-electronic multi-channel cochlear implant (CI), which was
successfully implanted in 1977 and was the basis for what is known as
the modern CI today. This laid the foundation for the successful growth
of the company in 1990, when they hired their first employees. To date,
MED-EL has grown to more than 1,900 employees and 30 subsidiaries

The company offers the widest range of implantable and non-implantable
solutions to treat all types of hearing loss, enabling people in 121
countries to enjoy the gift of hearing with the help of a MED-EL device.
MED-EL's global portfolio of hearing solutions includes cochlear and
middle ear implant systems, a combined Electric Acoustic Stimulation
hearing implant system as well as bone conduction devices.

1 Hearing Loss Association of America. Types,
Causes and Treatment
. Accessed April 26, 2018.

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