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510(k) Data Aggregation
K Number
K041302Device Name
REFUGE SOUND GENERATOR
Manufacturer
Date Cleared
2004-07-01
(48 days)
Product Code
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
MICRO-EAR TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Refuge Tinnitus Maskers styles are In-The Canal and Behind-The-Ear that are electronic; air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Refuge Tinnitus Masker is intended for those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus
Device Description
electronic; air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Refuge Tinnitus Maskers styles are In-The Canal and Behind-The-Ear.
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K Number
K972431Device Name
MERIDIAN DSP
Manufacturer
Date Cleared
1997-07-23
(29 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
MICRO-EAR TECHNOLOGY, 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: Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance To Loudness.
Device Description
Meridian DSP (Hearing Aid)
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K Number
K970880Device Name
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
Manufacturer
Date Cleared
1997-06-06
(88 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
MICRO-EAR TECHNOLOGY, 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 weak sound and attenuate strong sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category (ies). (Check appropriate space (s)): Severity: 1. Slight, 2. Mild, 3. Moderate, 4. Severe. Frequency: 1. High Frequency, 2. Gradually Sloping, 3. Reverse Slope, 4. Flat.
Device Description
The following hearing aids are available in full concha, I.T.E., low profile, and half shells.
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K Number
K964657Device Name
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
Manufacturer
Date Cleared
1997-02-11
(83 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
MICRO-EAR TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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