FDA.reportPublic FDA data

Eargo RX

Primary DI
00850010429274
Brand
Eargo RX
Company
Eargo, Inc.
Model
99-0178-001
Device description
Eargo SE-Rx New System
Published
2024-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QDDSelf-Fitting Air-Conduction Hearing Aid, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDDSelf-Fitting Air-Conduction Hearing Aid, PrescriptionEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221698000Eargo 5 , Eargo 6Eargo, Inc.2022-12-21QUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010429274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010429274008500104292748500104292740850010429274

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (855) 690-9360info@eargo.com

Regulatory Flags#

DUNS number
079865289
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010429786Eargo 899-0179-001-U2026-04-20
00850010429847Eargo SE99-0201-0012026-04-20
00850010429779Eargo SE99-0198-0012025-10-22
00850010429205Eargo RX99-0177-0012024-06-17
00850010429403Eargo 799-0156-0012023-03-20
00850010429304Eargo 899-0179-0012025-05-13
00850010429328Eargo 899-0180-0012025-05-13
00850010429540Eargo 899-0181-0012025-05-13
00850010429687Eargo 899-0182-0012025-05-13
00850010429694Eargo 899-0184-0012025-05-13
00850010429700Eargo 899-0185-0012025-05-13
00850010429717Eargo 899-0186-0012025-05-13
00850010429724Eargo 899-0187-0012025-05-13
00850010429793Eargo 899-0193-0012025-05-13
00850010429809Eargo 899-0196-0012025-05-13
00850010429816Eargo SE99-0197-0012025-04-07
00850010429731Eargo SE99-0188-0012025-04-03
00850010429748Eargo SE99-0189-0012025-04-03
00850010429755Eargo SE99-0190-0012025-04-03
00850010429762Eargo SE99-0191-0012025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850010429205Eargo RXEargo, Inc.QDD2024-06-17
05708296231010GN HearingGn Hearing A/SQDD2024-04-12
05708296231027GN HearingGn Hearing A/SQDD2024-04-12
05708296231034GN HearingGn Hearing A/SQDD2024-04-12
05708296231041GN HearingGn Hearing A/SQDD2024-04-12
05708296237944GN HearingGn Hearing A/SQDD2024-04-12
05708296237951GN HearingGn Hearing A/SQDD2024-04-12
05708296237968GN HearingGn Hearing A/SQDD2024-04-12
05708296237975GN HearingGn Hearing A/SQDD2024-04-12
05714880199420SonyWs Audiology Usa, Inc.QDD2023-08-31
05714880182781SonyWs Audiology Usa, Inc.QDD2023-05-30
05714880189308SonyWs Audiology Usa, Inc.QDD2023-01-20
05714880182750SonyWs Audiology Usa, Inc.QDD2022-12-20
05708296260775GN HearingGn Hearing A/SQDD2022-12-08
05708296260782GN HearingGn Hearing A/SQDD2022-12-08
05708296260799GN HearingGn Hearing A/SQDD2022-12-08
00850022464645Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
00850022464577Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
10850022464642Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
05714880182743SonyWs Audiology Usa, Inc.QDD2022-09-12
00850022464638Lexie B2, Powered by BoseHEARX GROUP (PTY) LTDQDD2022-09-09
00850022464492Lexie B1, Powered by BoseHEARX GROUP (PTY) LTDQDD2022-08-01
05708296228706GN HearingGn Hearing A/SQDD2022-07-08
05708296228713GN HearingGn Hearing A/SQDD2022-07-08
05708296233656GN HearingGn Hearing A/SQDD2022-07-08
05708296237609GN HearingGn Hearing A/SQDD2022-07-08
05708296238040GN HearingGn Hearing A/SQDD2022-07-08
05708296238057GN HearingGn Hearing A/SQDD2022-07-08
05708296238064GN HearingGn Hearing A/SQDD2022-07-08
05708296238071GN HearingGn Hearing A/SQDD2022-07-08