FDA.reportPublic FDA data

EarQ

Primary DI
05714464097173
Brand
EarQ
Company
Sbo Hearing A/S
Model
255027
Device description
E40 FW 1.0.0
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714464097173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714464097173057144640971735714464097173

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid wireless-fitting computer-aided setA collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer application software and a neck loop to establish the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal (CIC) types.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100loek@demant.com

Regulatory Flags#

DUNS number
306018410
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714464175659Maico2860902026-04-10
05714464175666Maico2860912026-04-10
05714464175673Maico2860922026-04-10
05714464175680Maico2860932026-04-10
05714464175697Maico2860942026-04-10
05714464175703Oticon2860952026-04-10
05714464175710Oticon2860962026-04-10
05714464175727Oticon2860972026-04-10
05714464175734Oticon2860982026-04-10
05714464175741Oticon2860992026-04-10
05714464175857Oticon2861102026-04-10
05714464175864Oticon2861112026-04-10
05714464175871Oticon2861122026-04-10
05714464175888Oticon2861132026-04-10
05714464175895Oticon2861142026-04-10
05714464175963Oticon2861212026-04-10
05714464176175Bernafon2861422026-04-10
05714464176182Bernafon2861432026-04-10
05714464176199Bernafon2861442026-04-10
05714464176205Bernafon2861452026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880295054SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295061SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295078SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295689SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295764SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295771SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295825SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295832SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295887SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295894SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295948SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295955SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295962SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295979SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296006SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296037SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296068SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296099SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
07613389834147Phonak Audéo E90-Sphere Sonova AGKLW2026-03-17
07613389860498Phonak Audéo E30-Sphere Sonova AGKLW2026-03-17
07613389891171Phonak Audéo E90-RSonova AGKLW2026-03-16
05714464175529BernafonSbo Hearing A/SKLW2026-02-25
05714464175567NeutralSbo Hearing A/SKLW2026-02-25
05714464175598PhilipsSbo Hearing A/SKLW2026-02-25
05714464175628OticonSbo Hearing A/SKLW2026-02-25
05714464176151PhilipsSbo Hearing A/SKLW2026-02-25
05714464176168PhilipsSbo Hearing A/SKLW2026-02-25
05714464176335OticonSbo Hearing A/SKLW2026-02-25
05714464176359OticonSbo Hearing A/SKLW2026-02-25
05714464182848OticonSbo Hearing A/SKLW2026-02-25