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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-98
In Commercial Distribution

  • 06937572800049 ()


  • Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-96
In Commercial Distribution

  • 06937572800032 ()


  • Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-95
In Commercial Distribution

  • 06937572800025 ()


  • Air-conduction hearing aid, wearable case
Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-93
In Commercial Distribution

  • 06937572800018 ()


  • Air-conduction hearing aid, wearable case
Wearable air-conduction hearing aid - wearable sound-amplifying device that is intended to compensate for impaired hearing.
BEURER NORTH AMERICA, L.P.
HA50 (Art.- No. 641.71)
In Commercial Distribution

  • 00853879007027 ()
  • 10853879007024 ()
  • 20853879007021 ()


  • Air-conduction hearing aid, wearable case
A 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, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an ear tip that fits inside the the ear canal. 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
IHEAR MEDICAL, INC.
EON-KIT-STD
In Commercial Distribution

  • 00850965008470 ()
  • 00850965008456 ()


  • Air-conduction hearing aid, wearable case
Jacoti Listen App 2.X
Jacoti
Jacoti Listen App 2.X
In Commercial Distribution

  • 05407004250014 ()


  • Air-conduction hearing aid, wearable case
No Description
Natus Medical Denmark ApS
NOAHLINK
In Commercial Distribution

  • 05713315004155 ()


  • Air-conduction hearing aid, wearable case
1081, LOUDSPEAKER
Natus Medical Denmark ApS
1081, LOUDSPEAKER
In Commercial Distribution

  • 05713315001093 ()
8-62-45200

  • Air-conduction hearing aid, wearable case
No Description
JLab
JLH-1
In Commercial Distribution

  • 00198168796207 ()


  • Air-conduction hearing aid, wearable case
No Description
JLab
JLH-2
In Commercial Distribution

  • 00198168321867 ()


  • Air-conduction hearing aid, wearable case
HEARING AID
PS Hearing Products Inc
PHSA-0001-00-00
In Commercial Distribution

  • 00196852460601 ()


  • Air-conduction hearing aid, wearable case
No Description
Elevoc Technology Co.,Ltd.
RIC 02
In Commercial Distribution

  • 06974346551417 ()
  • 69743465514172 ()
  • 69743465502193 ()


  • Air-conduction hearing aid, wearable case
No Description
Elevoc Technology Co.,Ltd.
RIC 01
In Commercial Distribution

  • 69743465514004 ()
  • 06974346551400 ()
  • 69743465501301 ()


  • Air-conduction hearing aid, wearable case
No Description
Xiamen New Sound Technology Co., Ltd.
Neosonic
In Commercial Distribution

  • 06945936703417 ()


  • Air-conduction hearing aid, wearable case
No Description
Xiamen New Sound Technology Co., Ltd.
BW51
In Commercial Distribution

  • 06945936703295 ()


  • Air-conduction hearing aid, wearable case
No Description
Xiamen New Sound Technology Co., Ltd.
Neosonice NW10
In Commercial Distribution

  • 06945936700256 ()


  • Air-conduction hearing aid, wearable case
No Description
Xiamen New Sound Technology Co., Ltd.
Clarity10
In Commercial Distribution

  • 06945936701796 ()


  • Air-conduction hearing aid, wearable case
No Description
Xiamen New Sound Technology Co., Ltd.
EUBW21
In Commercial Distribution

  • 06945936700812 ()


  • Air-conduction hearing aid, wearable case
No Description
Xiamen New Sound Technology Co., Ltd.
EU1080P
In Commercial Distribution

  • 06945936700799 ()


  • Air-conduction hearing aid, wearable case
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