Advanced Bionics LLC Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss
Brand
Advanced Bionics LLC
Lot Codes / Batch Numbers
Model #AB-7300, Serial Numbers: 36241, 36242, 36243, 36244, 36245, 36246, 36247, 36248, 36249, 36250, 36251, 36252, 36253, 36254, 36255, 36256, 36257, 36258, 36259, 36260, 36261, 36262, 36263, 36264, 36265, 36266, 36267, 36268, 36269, 36270, 36271, 36272, 36273, 36274, 36275, 36276, 36291, 36292, 36293, 36295, 36297, 36298, 36299, 36300, 36324, 36325, 36326, 36327, 36328, 36329, 36330, 36331, 36332, 36333, 36334, 36335, 36336, 36338, 36339, 36340, 36341, 36342, 36343, 36344, 36345, 36346, 36347, 36348, 36349, 36350, 36351, 36352, 36353, 36354, 36355, 36356, 36357, 36358, 36359, 36360, 36481, 36482, 36483, 36484 36485, 36486, 36487, 36488, 36489, 36490, 36491, 36493, 36494, 36495, 36496, 36497, 36498, 36499, 36500, 36501, 36502, 36503, 36504, 36506, 36507, 36508, 36509, 36510, 36511, 36512, 36513, 36514, 36515 36516, 36517, 36518, 36519, 36520, 36521, 36522, 36523, 36524, 36525, 36526, 36527, 36528, 36529 36530, 36531, 36532, 36533, 36534, 36535, 36536, 36537, 36538, 36539, 36540, 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Products Sold
Model #AB-7300; Serial Numbers: 36241, 36242, 36243, 36244, 36245, 36246, 36247, 36248, 36249, 36250, 36251, 36252, 36253, 36254, 36255, 36256, 36257, 36258, 36259, 36260, 36261, 36262, 36263, 36264, 36265, 36266, 36267, 36268, 36269, 36270, 36271, 36272, 36273, 36274, 36275, 36276, 36291, 36292, 36293, 36295, 36297, 36298, 36299, 36300, 36324, 36325, 36326, 36327, 36328, 36329, 36330, 36331, 36332, 36333, 36334, 36335, 36336, 36338, 36339, 36340, 36341, 36342, 36343, 36344, 36345, 36346, 36347, 36348, 36349, 36350, 36351, 36352, 36353, 36354, 36355, 36356, 36357, 36358, 36359, 36360, 36481, 36482, 36483, 36484 36485, 36486, 36487, 36488, 36489, 36490, 36491, 36493, 36494, 36495, 36496, 36497, 36498, 36499, 36500, 36501, 36502, 36503, 36504, 36506, 36507, 36508, 36509, 36510, 36511, 36512, 36513, 36514, 36515 36516, 36517, 36518, 36519, 36520, 36521, 36522, 36523, 36524, 36525, 36526, 36527, 36528, 36529 36530, 36531, 36532, 36533, 36534, 36535, 36536, 36537, 36538, 36539, 36540, 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Advanced Bionics LLC is recalling Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech pr due to Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can
Recommended Action
Per FDA guidance
Advanced Bionics is notifying clinicians of this situation so that they can provide appropriate clinical management. The notification letter sent to clinicians in the United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the number of headpiece-related complaints, firm advises of the potential clinical symptoms: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps. Per the letter, as long as the system maintains lock, there is no degradation in sound quality or stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal. Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026