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Sign in to claim this brandGeneral Hearing Instruments, Inc.
US
Last updated May 23, 2026
What General Hearing Instruments, Inc. makes
General Hearing Instruments, Inc. manufactures custom and pre-molded in-the-ear hearing aids, including behind-the-ear (BTE) and canal models. Their product line includes devices like the AURIS series (AE, TL, HS, AC, MM, COE, CIC) and the TRANQUIL TRI series (OE, COE, CIC, BTE), designed for various hearing loss profiles and ear canal shapes.
These devices are regulated under FDA’s Class I and Class II classifications, with some models authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does General Hearing Instruments, Inc. manufacture?
General Hearing Instruments, Inc. specializes in hearing aids designed to fit inside or near the ear. Their product line includes custom and pre-molded in-the-ear devices, such as the AURIS series (including AE, TL, HS, AC, MM, COE, and CIC models) and the TRANQUIL TRI series (OE, COE, CIC, and BTE). These devices are tailored for different hearing loss types and ear canal anatomies, ranging from open-ear designs to fully canal-inserted or behind-the-ear models.
Where is General Hearing Instruments, Inc. based?
The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and product listings confirm its operational base within the country.
Which regulatory registries or databases list General Hearing Instruments, Inc.’s devices?
General Hearing Instruments, Inc.’s devices are listed in the FDA’s 510(k) database. This registry includes hearing aids that have undergone the 510(k) premarket notification process, demonstrating their compliance with FDA requirements for marketing in the U.S. The listing confirms these specific models have been authorised through this pathway.
How are General Hearing Instruments, Inc.’s devices classified under FDA regulations?
General Hearing Instruments, Inc.’s devices fall under FDA’s Class I and Class II classifications. Class I generally covers low-risk devices requiring general controls, while Class II includes those with a moderate risk that may require special controls. The specific classification depends on factors like the device’s intended use, design, and potential risks, as outlined in FDA’s regulatory framework for hearing aids.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (65)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Beige,Pair | FDA UDI | Class II | Active |
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Beige,Left | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,Polytube,Brown,Right | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Beige,Left | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Black,Left | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Black,Right | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Brown,Left | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,Custom,Pair | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,Polytube,Black,Pair | FDA UDI | Class II | Active |
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Brown,Right | FDA UDI | Class II | Active |
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Brown,Pair | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,Polytube,Beige,Pair | FDA UDI | Class II | Active |
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Grey,Pair | FDA UDI | Class II | Active |
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Beige,Right | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Beige,Pair | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Grey,Right | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,Custom,Right | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Grey,Right | FDA UDI | Class II | Active |
| Simply Tranquil I | Simply Tranquil I,10A,Digital,Right | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,Polytube,Beige,Right | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Beige,Pair | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Black,Pair | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Grey,Left | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Grey,Pair | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Grey,Pair | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Black,Right | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,Polytube,Black,Right | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Black,Pair | FDA UDI | Class II | Active |
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Black,Right | FDA UDI | Class II | Active |
| Simply Tranquil I | Simply Tranquil I,10A,Digital,Left | FDA UDI | Class II | Active |
| Tinnitus Masker | Tinnitus,Custom,Left | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Beige,Left | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Brown,Right | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Brown,Left | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Brown,Right | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,Custom,Left | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,Polytube,Grey,Right | FDA UDI | Class II | Active |
| Simply Tranquil II | Simply Tranquil II,10A,Digital,Pair | FDA UDI | Class II | Active |
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Grey,Left | FDA UDI | Class II | Active |
| Tinnitus Masker | Tinnitus,Custom,Pair | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Brown,Pair | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Beige,Right | FDA UDI | Class II | Active |
| Tranquil II OTE | Tranquil II,OTE,10A,Digital,Grey,Left | FDA UDI | Class II | Active |
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Grey,Right | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,RIC,Brown,Pair | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,Polytube,Grey,Left | FDA UDI | Class II | Active |
| Triad Combonation Unit | Triad Combo,OTE,10A,Digital,Polytube,Black,Left | FDA UDI | Class II | Active |
| Simply Tranquil I | Simply Tranquil I,10A,Digital,Pair | FDA UDI | Class II | Active |
| Tinnitus Masker | Tinnitus,Custom,Right | FDA UDI | Class II | Active |
| Tranquil I OTE | Tranquil I,OTE,10A,Digital,Black,Pair | FDA UDI | Class II | Active |
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