FDA approves a remote feature to cochlear implant system

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Cochlear implant

A cochlear implant (CI) is a surgical device provides a sense of sound to a intense deaf persons or severely hard-of-hearing. The implant consists of an external portion in the ear and a second portion that is surgically placed under the skin.

The divisions of this implant are.

  • Microphone picks up sound from the environment.
  • A speech processor, which selects and arranges sounds picked up by the microphone.
  • A transmitter and receiver receive the signals from the speech processor and convert them into electric impulses.
  • An electrode array is a group of electrodes that collects the impulses from the stimulator and sends them to different regions of the auditory nerve.

This implant useful for deaf persons, because the sounds in the environment and help him or her to understand speech.

FDA approves Cochlear Implant System by a telemedicine platform

Now, the U.S. Food and Drug Administration approved programming sessions for the Nucleus Cochlear Implant System by a telemedicine platform.

A cochlear implant or hybrid hearing is an effective and long-term solution for people with extreme hearing loss. Cochlear implant technology is the world’s industry leader.

The Cochlear remote programming feature is indicated for patients who have had six months of experience with their cochlear implant sound processor and are comfortable with the programming process.

“Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants. Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to patients and their families, especially those who must travel great distances or need frequent adjustments,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic.

The electronic device produces useful hearing sensations to a person by electrically stimulating nerves inside the inner ear.

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According to the National Institutes of Health, researchers implanted cochlear implant in 58,000 adults and 38,000 children’s.

Cochlear implant requires programming visits

Cochlear implant requires programming visits. In these visits, an audiologist adjusts various electronic settings that control the implant stimulation in the nerves inside the inner ear, such as adjustments in sensitivity to low-level sound or limits on loud sounds.

Due to this in turn changes patient recognizes different sounds, such as speech or music in different environments. While speaking, these adjustments improve the patient’s quality of life by adjusting their ability to understand speech, comfort in loud environments or independence in performing daily tasks.

However, the FDA conducts a clinical study and collects a data from 39 patients. They assign a programming session and two remote programming sessions to each patient, and approximately two months apart.

After each session, the speech perception tests showed no significant difference between in-person and remote programming. The FDA also evaluated data from patient’s self-assessment of their ability to hear speech in the presence of other sounds and sense the direction, distance and motion of sound.

Also, the FDA assessed the cyber security measures for the remote interaction. The FDA granted the approval of the Nucleus Cochlear Implant System to Cochlear Americas.

Benefits

This quality implant mostly helps to adults with severe both ears. Also, 12 months children or older with average to intense hearing loss in both ears are not receiving enough benefit when using hearing aids.

Although, there is no cure for hearing loss. However, the cochlear implant recognized as an established treatment for hearing loss.