FDA.reportPublic FDA data

Eargo 6

Primary DI
00850010429366
Brand
Eargo 6
Company
Eargo, Inc.
Model
99-0147-001
Device description
Eargo 6 System
Published
2021-12-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air Conduction With Wireless Technology
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2
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
00850010429366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010429366008500104293668500104293660850010429366

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
00850010429779Eargo SE99-0198-0012025-10-22
00850010429786Eargo 899-0179-001-U2026-04-20
00850010429847Eargo SE99-0201-0012026-04-20
00850010429540Eargo 899-0181-0012025-05-13
00850010429793Eargo 899-0193-0012025-05-13
00850010429205Eargo RX99-0177-0012024-06-17
00850010429403Eargo 799-0156-0012023-03-20
00850010429304Eargo 899-0179-0012025-05-13
00850010429328Eargo 899-0180-0012025-05-13
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
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
07613389927696Phonak CROS E-RSonova AGOSM2026-08-03
07613389927719Phonak CROS E-RSonova AGOSM2026-08-03
07613389927726Phonak CROS E-RSonova AGOSM2026-08-03
07613389927733Phonak CROS E-RSonova AGOSM2026-08-03
07613389927740Phonak CROS E-RSonova AGOSM2026-08-03
07613389927757Phonak CROS E-RSonova AGOSM2026-08-03
07613389927764Phonak CROS E-RSonova AGOSM2026-08-03
07613389927771Phonak CROS E-RSonova AGOSM2026-08-03
07613389928181Phonak CROS E-RSonova AGOSM2026-08-03
05714878800291MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800307MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800314MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800352MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
07613389840599Moxi S9-RXSonova AGOSM2026-07-26
07613389840605Moxi S9-RXSonova AGOSM2026-07-26
07613389842012Moxi S7-RXSonova AGOSM2026-07-26
07613389842029Moxi S7-RXSonova AGOSM2026-07-26
07613389842036Moxi S7-RXSonova AGOSM2026-07-26
07613389842043Moxi S7-RXSonova AGOSM2026-07-26
07613389842050Moxi S7-RXSonova AGOSM2026-07-26
07613389842067Moxi S7-RXSonova AGOSM2026-07-26
07613389842074Moxi S9-RXSonova AGOSM2026-07-26
07613389842081Moxi S9-RXSonova AGOSM2026-07-26
07613389842098Moxi S9-RXSonova AGOSM2026-07-26
07613389842104Moxi S9-RXSonova AGOSM2026-07-26
07613389842111Moxi S-RX FLEX:TRIALSonova AGOSM2026-07-26
07613389843682Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389843699Relate5.0 RIC RX DEMOSonova AGOSM2026-07-26
07613389844627Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844634Relate5.0 Gold RIC RXSonova AGOSM2026-07-26