Category: Cochlear Implants

Cochlear Implants

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Cochlear Nucleus Receives FDA Approval for UHL/SSD

Cochlear implants are already FDA approved for those with moderate-to-profound bilateral sensorineural hearing loss. With this approval, Cochlear can expand implantable treatment options for those with UHL/SSD to include cochlear implants, for the first time, according to its announcement.

Cochlear Implants

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When Is an Implantable Hearing Solution Appropriate?

George Cire, Chris James, and Paula Greenham review the major treatment modalities, the general indications for implant use and referral, and present a picture of current clinical practice as reflected in Cochlear Ltd’s Implant Recipient Observational Study (IROS).

Cochlear Implants

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Cochlear’s Baha 6 Max Receives FDA Clearance

Cochlear Limited (ASX: COH) announced the Food and Drug Administration (FDA)'s clearance of the new Cochlea Baha 6 Max Sound Processor, designed to “improve hearing outcomes for people with SSD (single-sided deafness), conductive or mixed hearing loss.”

IotaMotion, Inc Announces Completion of Robotics-Assisted Cochlear Implant Insertions Using IotaSOFT System

This study is intended to gather confirmatory clinical evidence in support of the safety and performance of the investigational iotaSOFT system when used as a surgical support instrument during cochlear implant surgery with adults. These data will be used to support the company’s de novo premarket submission with the FDA.

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Cochlear Launches ‘Hearing Aid Check’ Tool

The tool allows adults with hearing aids who are struggling to hear to learn if they may benefit from a cochlear implant. The tool aims to help participants, particularly in the aging adult population, compare their hearing performance with hearing aids to people with a cochlear implant, and depending on their results, to seek further hearing healthcare advice to treat their loss.

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