Profile: GN Otometrics A/S is a manufacturer of hearing & balance instrumentation software. Our software concepts are designed to help healthcare professionals make better decisions. Our ICS chartr 200 provides a complete test battery for diagnosing a wide range of balance and dizziness disorders, thus allowing focused patient care from diagnosis through treatment. We offer products such as hearing assessment, fitting systems, balance assessment, & OTOsuiteT software universe. The fitting system offers fittings & testing which focuses on solutions for hearing care professionals dispensing hearing instruments. The PC-based Aurical system has set the industry standard for hearing instrument fitting equipment interfacing seamlessly with Noah, the fitting and programming standard for the hearing instrument industry. The Aurical handles virtually every audio logic function necessary in a hearing clinic, yet is lightweight and easily portable.

The company has revenues of USD 5-10 Million, has ~30 employees and is ISO 9000, CE certified.

FDA Registration Number: 3004633966
US Agent: David Vizenor / Gn Otometrics North America
Phone: +1-(847)-534-6919  E-Mail:

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• Air Caloric Irrigator

• Air Conduction Hearing Aid (FDA Code: ESD / 874.3300) A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400).

• Audiometer Repair Services

• Audiometers (FDA Code: EWO / 874.1050) An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

• Audiometers & Accessories

• Auditory Evoked Potential Measuring Unit

• Auditory Impedance Tester (FDA Code: ETY / 874.1090) An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.

• Balance Platforms

• Brainstem Response Devices

• Caloric Air Stimulator (FDA Code: KHH / 874.1800) An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.

• Caloric Irrigator

• Caloric Water Stimulator (FDA Code: ETP / 874.1800)

• Clinical Middle Ear Analyzers

• Computer Softwares

• Couplers

• Diagnostic Flexible Fresnel Lens (FDA Code: HJJ / 886.1390) A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly refractive zones. The device is intended to be applied to the back of the spectacle lenses of patients with aphakia (absence of the lens of the eye).

• Diagnostic Middle Ear Analyzers

• Diagnostic Test Kits

• Earphones, Audiometric Testing

• Electronystagmograph

• Electronystagmographic Electrode

• Electronystagmography

• Electronystagmography (ENG) Systems

• ENT Analyzers

• ENT Computer Software

• ENT Educational Materials

• ENT Examining/Treatment Unit (FDA Code: ETF / 874.5300) An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.

• ENT Measurement Systems

• Evoked Response Auditory Stimulator (FDA Code: GWJ / 882.1900) An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

• Evoked Response Testing Systems

• Exam Tables

• Force-Measuring Platform (FDA Code: KHX / 890.1575) A force-measuring platform is a device intended for medical purposes that converts pressure applied upon a planar surface into analog mechanical or electrical signals. This device is used to determine ground reaction force, centers of percussion, centers of torque, and their variations in both magnitude and direction with time.

• Handheld Middle Ear Analyzer

• Hearing Aid / Earphone and Analysis Systems (FDA Code: ETW / 874.3310) A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.

• Hearing Instrument Analyzers

• Hearing Instruments

• Impedance Testing Systems

• Infant Screening & Testing Units

• Medical Exam Tables

• Middle Ear Analyzer

• Middle Ear Analyzer, Tympanometer

• Nursing Computer Software

• Nystagmograph, Monitor (FDA Code: GWN / 882.1460) A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

• Opticokinetic Drum (FDA Code: HOW / 886.1200) An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.

• Otoacoustic Emission Systems

• Otoacoustic Emission Test Equipment

• Otoscopes

• Otoscopes (FDA Code: ERA / 874.4770) An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

• Pediatric ENT Testing Kits

• Portable Tympanometric Instruments