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510(k) Data Aggregation
K Number
K050653Device Name
TRANSEAR BONE CONDUCTION HEARING AID
Manufacturer
Date Cleared
2005-07-01
(112 days)
Product Code
Regulation Number
874.3302Why did this record match?
Applicant Name (Manufacturer) :
UNITED HEARING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TransEAR™ Bone Conduction Hearing Aid is indicated for persons with single sided deafness to provide the perception of sound from the deaf ear. The amplified signal is received into the deaf ear and transferred through the bones of the skull to the better cochlea.
Device Description
TransEAR™ is a bone conduction hearing aid. Unlike conventional air-conduction hearing aids, which depend on acoustic coupling through the air, TransEAR™ utilizes bone conduction technology to transmit sound vibrations through the bones of the skull to the cochlea.
TransEAR™ consists of a processor and a transducer (oscillator) connected via a wire cable. TransEAR's processor uses conventional digital hearing aid technology housed in a conventional behind-the-ear aid housing. The transducer is a mechanical oscillator housed in a conventional ear mold made of standard ear mold material. Each ear mold is custom made from an impression of the wearer's ear. A standard Zinc-Air hearing aid battery is utilized for power.
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K Number
K970828Device Name
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER
Manufacturer
Date Cleared
1997-05-28
(83 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
UNITED HEARING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: x 1. Slight x 2. Mild x 3. Moderate Configuration: x 1. High Frequency -Precipitously Sloping x 2. Gradually Sloping x 3. Reverse Slope x 4. Flat Other x 1. Low tolerance To Loudness
Device Description
UHS MicroNET Programmable Air Conduction Hearing Aids and Programmer Model Nos .; This hearing aid comes in your choice of models, as follows: Full Concha --P901 Demi Concha --P902 Custom Canal --P903 Mini Canal --P903m Low Profile --P906 CIC CanalMate --P909 All the above models are available in a choice of one of two circuits, the Etymotic DSD K-AMP circuit and the Gennum DSD-DynamEQ II circuit. The hearing aids are programmed using the UHS microNET Programmer, a handheld device. The aids can be fit to hearing impaired individuals with mild to moderate hearing losses. Because of the range of the programming, the aid can fit most all audiogram configurations and has provisions for patients with low tolerance to loud sounds.
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