FDA.reportPublic FDA data

Eargo SE

Primary DI
00850010429779
Brand
Eargo SE
Company
Eargo, Inc.
Model
99-0198-001
Device description
Eargo SE & Deep Cleaning Kit Bundle
Published
2025-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterEar, 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
00850010429779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010429779008500104297798500104297790850010429779

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.

Regulatory Flags#

DUNS number
079865289
Device count
1
Serial number
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
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
00850010429588Eargo SE99-0162-0012024-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810153660323Lexie B3 Hearing AidsHEARX GROUP (PTY) LTDQUH2026-05-07
00850010429786Eargo 8Eargo, Inc.QUH2026-04-20
00850010429847Eargo SEEargo, Inc.QUH2026-04-20
06971094538561HARMONIXHuizhou Jinghao Medical Technology Co., LtdQUH2026-01-20
00810153660811Lexie HearingHEARX GROUP (PTY) LTDQUH2025-07-31
00850010429304Eargo 8Eargo, Inc.QUH2025-05-13
00850010429328Eargo 8Eargo, Inc.QUH2025-05-13
00850010429540Eargo 8Eargo, Inc.QUH2025-05-13
00850010429687Eargo 8Eargo, Inc.QUH2025-05-13
00850010429694Eargo 8Eargo, Inc.QUH2025-05-13
00850010429700Eargo 8Eargo, Inc.QUH2025-05-13
00850010429717Eargo 8Eargo, Inc.QUH2025-05-13
00850010429724Eargo 8Eargo, Inc.QUH2025-05-13
00850010429793Eargo 8Eargo, Inc.QUH2025-05-13
00850010429809Eargo 8Eargo, Inc.QUH2025-05-13
00046838505065JVCNovidan, Inc.QUH2025-05-07
00850010429816Eargo SEEargo, Inc.QUH2025-04-07
00850010429731Eargo SEEargo, Inc.QUH2025-04-03
00850010429748Eargo SEEargo, Inc.QUH2025-04-03
00850010429755Eargo SEEargo, Inc.QUH2025-04-03
00850010429762Eargo SEEargo, Inc.QUH2025-04-03
06971094538097OXILINEHuizhou Jinghao Medical Technology Co., LtdQUH2025-03-24
16971094538094OXILINEHuizhou Jinghao Medical Technology Co., LtdQUH2025-03-24
06971094537991AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2025-02-25
16971094537998AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2025-02-25
00860010331033CeretoneAudicon CorporationQUH2024-09-04
10860010331030CeretoneAudicon CorporationQUH2024-09-04
06971094537793RETEKESSHuizhou Jinghao Medical Technology Co., LtdQUH2024-09-02
16971094537790RETEKESSHuizhou Jinghao Medical Technology Co., LtdQUH2024-09-02
06971094537748AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2024-08-14