Otologics LLC is a

medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

company that produces

middle ear The middle ear is the portion of the ear medial to the eardrum, and distal to the oval window of the cochlea (of the inner ear). The mammalian middle ear contains three ossicles, which transfer the vibrations of the eardrum into waves in the ...

hearing Hearing, or auditory perception, is the ability to perceive sounds through an organ, such as an ear, by detecting vibrations as periodic changes in the pressure of a surrounding medium. The academic field concerned with hearing is audit ...

implant Implant can refer to: Medicine * Implant (medicine), or specifically: **Brain implant **Breast implant ** Buttock implant **Cochlear implant **Contraceptive implant **Dental implant ** Fetal tissue implant ** Implantable cardioverter-defibrillato ...

s. Its headquarters are located in

Boulder, Colorado Boulder is a home rule city that is the county seat and most populous municipality of Boulder County, Colorado, United States. The city population was 108,250 at the 2020 United States census, making it the 12th most populous city in Colora ...

, with offices and a distribution network throughout

Europe Europe is a large peninsula conventionally considered a continent in its own right because of its great physical size and the weight of its history and traditions. Europe is also considered a Continent#Subcontinents, subcontinent of Eurasia ...

Asia Asia (, ) is one of the world's most notable geographical regions, which is either considered a continent in its own right or a subcontinent of Eurasia, which shares the continental landmass of Afro-Eurasia with Africa. Asia covers an are ...

, and

Latin America Latin America or * french: Amérique Latine, link=no * ht, Amerik Latin, link=no * pt, América Latina, link=no, name=a, sometimes referred to as LatAm is a large cultural region in the Americas where Romance languages — languages derived ...

.Otologics official websit
About us
Retrieved 2011-03-18PR Newswire Association LLC. Otologics, Maker of the Carina (TM) Fully Implantable Hearing Device, Will Demonstrate This Breakthrough Technology at the European Academy of Neural Otology, in Cologne, Germany September 20 to 24th. The Free Library by Farflex. Retrieved 2011-03-18 http://thefreelibrary.com/Otologics,+Maker+of+the+Carina(TM)+Fully+Implantable+Hearing+Device,...-a0151609241 The development of Otologics'

s began with the work of John M. Fredrickson, M.D., in the 1970s and 80s while he was a surgeon and researcher at the

Washington University School of Medicine Washington University School of Medicine (WUSM) is the medical school of Washington University in St. Louis in St. Louis, Missouri. Founded in 1891, the School of Medicine has 1,260 students, 604 of which are pursuing a medical degree with ...

in St. Louis, Missouri. In 1996, Otologics LLC was founded in

Boulder In geology, a boulder (or rarely bowlder) is a rock fragment with size greater than in diameter. Smaller pieces are called cobbles and pebbles. While a boulder may be small enough to move or roll manually, others are extremely massive. In ...

Colorado Colorado (, other variants) is a state in the Mountain West subregion of the Western United States. It encompasses most of the Southern Rocky Mountains, as well as the northeastern portion of the Colorado Plateau and the western edge of the ...

by Jose Bedoya. Otologics LLC filed for Chapter 11 bankruptcy in July 2012 and is currently negotiating with a possible buyer and seeking DIP financing.

Products

Otologics produces Carina and MET,

s which bypass the

ear canal The ear canal (external acoustic meatus, external auditory meatus, EAM) is a pathway running from the outer ear to the middle ear. The adult human ear canal extends from the pinna (anatomy), pinna to the eardrum and is about in length and in di ...

and

eardrum In the anatomy of humans and various other tetrapods, the eardrum, also called the tympanic membrane or myringa, is a thin, cone-shaped membrane that separates the external ear from the middle ear. Its function is to transmit sound from the ...

Middle ear The middle ear is the portion of the ear medial to the eardrum, and distal to the oval window of the cochlea (of the inner ear). The mammalian middle ear contains three ossicles, which transfer the vibrations of the eardrum into waves in the ...

implantable hearing devices are relatively recent developments in the treatment of

hearing loss Hearing loss is a partial or total inability to hear. Hearing loss may be present at birth or acquired at any time afterwards. Hearing loss may occur in one or both ears. In children, hearing problems can affect the ability to acquire spoken l ...

, and, unlike conventional

hearing aids A hearing aid is a device designed to improve hearing by making sound audible to a person with hearing loss. Hearing aids are classified as medical devices in most countries, and regulated by the respective regulations. Small audio amplifiers su ...

, they are either partially or fully implanted within the body.Laura Johannes. Sweet Sounds: After years of failures and frustrations, implanted hearing aids appear to be on the horizon. Wall Street Journal, 2008. Retrieved 2011-05-11.http://newsroom.hei.org/pr/hri/sweet-sounds.aspx Otologics is one of three companies which produce middle ear hearing implants. The other two companies are Envoy Medical and Med-El Corporation. The Carina device is Otologics’

flagship A flagship is a vessel used by the commanding officer of a group of naval ships, characteristically a flag officer entitled by custom to fly a distinguishing flag. Used more loosely, it is the lead ship in a fleet of vessels, typically the ...

product and it includes a

rechargeable battery A rechargeable battery, storage battery, or secondary cell (formally a type of energy accumulator), is a type of electrical battery which can be charged, discharged into a load, and recharged many times, as opposed to a disposable or prima ...

and a

microphone A microphone, colloquially called a mic or mike (), is a transducer that converts sound into an electrical signal. Microphones are used in many applications such as telephones, hearing aids, public address systems for concert halls and publ ...

that is implanted entirely under the skin. Carina and MET received their

CE mark On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificat ...

in October 2006L.Bruschini, F. Forli, A. Santoro, P. Bruschini, S. Berrettini. Fully implantable Otologics MET Carina device for the treatment of sensorineural hearing loss. Preliminary surgical and clinical results. ACTA Otorhinolaryngologica Italia 2009; 29:79-85. Retrieved 2011-05-05. http://www.actaitalica.it/issues/2009/2-09/Bruschini.pdf and are sold throughout

and

. In the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country Continental United States, primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., ...

, Otologics hearing implants are currently undergoing approval process by the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

References

{{DEFAULTSORT:Otologics Medical technology companies of the United States Manufacturing companies based in Boulder, Colorado Companies established in 1996