DevicePMAs@therightstef:P840024_S070 / 533-539
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Approval to implement a design change to the two-pin socket on the headset microphone. The transmitting coil is connected to the microphone via a cable which is plugged into this two-pinc socket. This change would also entail making a slight modification to the design of the shell of the headset microphone in order to accommodate the new design of the two-pin socket. The nucleus 22 channel cochlear implant is indicated for use in adults with bilateral, sensorineural, severe-to-profound deafness, ages 18 years and older, who obtain up to 30% speech recognition on tests of recorded sentence materials in the best-aided condition. It is indicated for use in children with bilateral, sensorineural, profound deafness, ages 2 years to 17 years, who obtain little or not benefit from conventional amplification in the best-aided test condition.
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