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510(k) Data Aggregation
K Number
K062404Device Name
TRANSEAR BONE CONDUCTION HEARING AID
Manufacturer
Date Cleared
2006-09-08
(22 days)
Product Code
Regulation Number
874.3302Why did this record match?
Applicant Name (Manufacturer) :
EAR TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TransEar® is intended for individuals with single sided deafness or unaidable unilateral hearing loss, with single sided deafness being defined as an ear having one or more of the following characteristics:
1) Profound sensorineural hearing loss of such magnitude that there is no perceived benefit from an air conduction hearing aid coupled to the same ear.
2) A hearing loss greater than 50 dB HTL at frequencies of 500 Hz 4000 Hz with speech recognition ability less than 50% when presented in quiet, at a 40 dB sensation level relative to the user's speech reception threshold.
3) A hearing loss greater than 50 dB HTL at frequencies of 500 Hz 4000 Hz with a small dynamic range, for loudness less than 20 dB for amplified speech, which makes the use of an air conduction hearing aid intolerable to the user.
The "better" cochlea should have pure tone air conduction thresholds 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 dB HTL or better at 3000 Hz.
For individuals with a "better" ear that exhibits a mixed or conductive hearing loss, bone conduction thresholds should be 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 db HTL or better at 3000 Hz,
Device Description
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K Number
K972776Device Name
DRY & STORE
Manufacturer
Date Cleared
1997-09-08
(45 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
EAR TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is used by hearing aid users as an accessory to remove Inis product is about by nearing overnight while they sleep.
Device Description
A hearing aid drying appliance is an accessory for use by hearing aid users to remove moisture that collects in the hearing aid during normal use. Various products, most using a desiccant, have been in use for many years. Dry & Store uses a desiccant, a fan, and heat all common technologies - to remove much of the moisture. Along with drying, the product features a sanitizing cycle using a 4-watt ultraviolet bulb, commonly in use for a number of applications outside the hearing aid accessory market.
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