FDA.reportPublic FDA data

Ceretone

Primary DI
00860010331033
Brand
Ceretone
Company
Audicon Corporation
Model
Beacon
Device description
OTC Hearing Aids, Color:Silver grey
Published
2024-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K221052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221052000Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.2023-09-25QUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860010331030PackageGS12In Commercial Distribution
20860010331037PackageGS120In Commercial Distribution
30860010331034PackageGS140In Commercial Distribution
40860010331031PackageGS1495In Commercial Distribution
00860010331033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001033103010860010331030
2086001033103720860010331037
3086001033103430860010331034
4086001033103140860010331031
00860010331033008600103310338600103310330860010331033

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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 profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Regulatory Flags#

DUNS number
118836847
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850065321417CeretoneCore One Pro2025-11-05
00850065321424CeretoneCore One Pro2025-11-05
00850065321431CeretoneCore One Pro2025-11-05
00850065321264CeretoneCore One ProCE-A90A(Beige)2025-06-04
00850065321295CeretoneCore One ProCE-A90A(Black)2025-06-04
00850065321301CeretoneCore One ProCE-A90A(White)2025-06-04
00850065321011CeretoneNexus2024-07-24
00860010331064CeretoneSolid2025-01-09
00860010331071CeretoneTorch2025-01-09
00860010331095CeretoneCore one2024-08-29
00860010331026CeretoneFusion2024-07-24
00850065321288CeretoneEssentialCE-A39HT(Skin)2025-06-04
00860010331002CeretoneEssentialCE-A39HT(White)2025-06-04
10850065321261CeretoneCore One ProCE-A90A(skin)2025-06-04
10850065321285CeretoneEssentialCE-A39HT(Skin)2025-06-04
10850065321292CeretoneCore One ProCE-A90A(Black)2025-06-04
10850065321308CeretoneCore One ProCE-A90A(White)2025-06-04
10860010331009CeretoneEssentialCE-A39HT(White)2025-06-04
00860010331057CeretoneStyle2025-01-09
10860010331061CeretoneSolid2025-01-09

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
00850010429779Eargo SEEargo, Inc.QUH2025-10-22
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
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