FDA.reportPublic FDA data

Philips

Primary DI
05714464148394
Brand
Philips
Company
Sbo Hearing A/S
Model
271210
Device description
HEARLINK 7050 CIC
Published
2025-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, tinnitus
LRBFace plate hearing aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2
LRBFace Plate Hearing AidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714464148394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714464148394057144641483945714464148394

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, canalA 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) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-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
+4523648485succ@demant.com

Regulatory Flags#

DUNS number
306018410
Device count
1
DM exempt
true
Serial number
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
05714880296440SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296860SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296877SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296884SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296891SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296907SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296914SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297010SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297027SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297034SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297041SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297058SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297065SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297072SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297188SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297195SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297201SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297218SIGNIAWs Audiology Usa, Inc.KLW2026-07-22