FDA Registration
Active
🇺🇸 United States
Hearing Lab Technology, LLC.
Reg #: 2523532
·
FEI: 2523532
·
Expires 2026
Products
5
Proprietary Names
45
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- Hearing Lab Technology, LLC.
- Registration Number
- 2523532
- FEI Number
- 2523532
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 806 Beaver St
- City
- West Bristol
- State
- PA
- ZIP
- 19007
- Country
- US
Owner / Operator
- Firm Name
- Hearing Lab Technology, LLC
- Operator Number
- 2523532
- Address
- 806 BEAVER ST., --
- City
- West Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
- Correspondent
- SUSAN - REID
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-10-19 |
| Kit, Earmold, Impression | LDG | Class 1 | Ear, Nose, Throat | No | 2022-07-15 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-10-19 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 1992-08-27 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2014-06-02 |
Proprietary Names
Engage, Engage Rechargeable,
OtoTech
Enrich Pro, Enrich
Liberty
Freedom
Accent
Ear Back Hearing Aid RITE16 9260
Ear Back Hearing Aid RITE64 3260
Elevate
America Hears
Ear Back Hearing Aid RITE96 4260
Aspire
Ear Back Hearing Aid RITE48 2260
Ear Back Hearing Aid RITE32 1260
Member's Selection OF16
Lucid
Member's Selection OF16 Model # 9249
BEHIND THE EAR ("BTE") HEARING AID
RITE96WL
Ear Back Hearing Aid RITEWL48 2360
Ear Back Hearing Aid RITEWL96 4360
Member's Selection A24
Member's Selection U128
Member's Selection A128
Present
Member's Selection U48
Member's Selection A48
Member's Selection U24
Member's Selection U128 Model # 5575
Ear Back Hearing Aid Models 246
Ear Back Hearing Aid Models 756
Member's Selection U48 Model # 2565
Member's Selection U24 Model # 7565
Universal
Ear Back Hearing Aid Models 256
Member's Selection A128 Model # 5465
Member's Selection A24 Model # 7465
Member's Selection A48 Model # 2465
Ultra
Ear Back Hearing Aid Models 557
Ear Back Hearing Aid Models 546
Ear Back Hearing Aid Models 446
Ear Back Hearing Aid Models 456
Ear Back Hearing Aid Models 746
Ear Back Hearing Aid Models 556
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device