PMA · Approved
Recalled · Class II · 2026Clarion Multi-Strategy Cochlear Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Bionics · MCM Implant, Cochlear
Approved on Jun 26, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 178-day review. It has been recalled 17 times.
- Decided
- Jun 26, 1997
- Review
- 178 days
- Class
- Class III
- Product code
- MCM
- Recalls
- 17
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P960058 has 149 supplements since 1997: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1997 | 1 |
| 1998 | 4 |
| 1999 | 5 |
| 2000 | 4 |
| 2001 | 1 |
| 2002 | 9 |
| 2003 | 4 |
| 2004 | 6 |
| 2005 | 6 |
| 2006 | 5 |
| 2007 | 3 |
| 2008 | 4 |
| 2009 | 5 |
| 2010 | 6 |
| 2011 | 3 |
| 2012 | 6 |
| 2013 | 7 |
| 2014 | 5 |
| 2015 | 7 |
| 2016 | 2 |
| 2017 | 7 |
| 2018 | 3 |
| 2019 | 15 |
| 2020 | 6 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 4 |
| 2025 | 4 |
| 2026 | 7 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MCM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2026 | Class II | Z-2283-2026 | Under Investigation by firm | Due to incorrect shelf-life expiration date. |
| Mar 23, 2026 | Class II | Z-1950-2026 | Under Investigation by firm | The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery. |
| Mar 5, 2025 | Class II | Z-1813-2025 | Under Investigation by firm | Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified. |
| Feb 17, 2020 | Class II | Z-2033-2020 | Device Design | hearing performance degradation due to body-fluid entering the device. |
| Feb 17, 2020 | Class II | Z-2032-2020 | Device Design | hearing performance degradation due to body-fluid entering the device. |
| Apr 4, 2019 | Class III | Z-1441-2020 | Software in the Use Environment | The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the… |
| Mar 18, 2019 | Class III | Z-1259-2020 | Other | Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. |
| Feb 6, 2019 | Class II | Z-1085-2019 | Process control | The sound processors were loaded with the incorrect firmware. |
| Feb 6, 2019 | Class II | Z-1084-2019 | Process control | The sound processors were loaded with the incorrect firmware. |
| Feb 6, 2019 | Class II | Z-1083-2019 | Process control | The sound processors were loaded with the incorrect firmware. |
| Jun 10, 2009 | Not classified | Z-2039-2009 | Process control | The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. These… |
| Jul 24, 2008 | Not classified | Z-0956-2009 | Employee error | 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… |
| Jul 24, 2008 | Not classified | Z-0958-2009 | Employee error | 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… |
| Jul 24, 2008 | Not classified | Z-0959-2009 | Employee error | 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… |
| Jul 24, 2008 | Not classified | Z-0957-2009 | Employee error | 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… |
| Mar 8, 2006 | Not classified | Z-0759-06 | Other | Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent… |
| Mar 8, 2006 | Not classified | Z-0758-06 | Other | Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent… |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MCM devicesMCM Implant, Cochlear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCM
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCM
Too few MCM 510(k)s in any year since 2007 to give a median.
Recalls per year · MCM
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MCM
5,418in 2025
MAUDE reports naming product code MCM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 17 | — | 1 | 1,639 |
| 2008 | 17 | — | 4 | 1,793 |
| 2009 | 19 | — | 2 | 1,897 |
| 2010 | 21 | — | 2 | 1,773 |
| 2011 | 27 | — | 1 | 2,293 |
| 2012 | 21 | — | 0 | 3,078 |
| 2013 | 28 | — | 0 | 2,689 |
| 2014 | 23 | — | 0 | 2,676 |
| 2015 | 23 | — | 0 | 3,105 |
| 2016 | 25 | — | 0 | 2,785 |
| 2017 | 31 | — | 0 | 3,122 |
| 2018 | 20 | — | 0 | 3,054 |
| 2019 | 35 | — | 0 | 3,405 |
| 2020 | 25 | — | 2 | 4,403 |
| 2021 | 20 | — | 0 | 5,260 |
| 2022 | 24 | — | 0 | 5,502 |
| 2023 | 18 | — | 0 | 5,727 |
| 2024 | 17 | — | 0 | 5,602 |
| 2025 | 17 | — | 0 | 5,418 |
| 2026 | 13 | — | 2 | — |
https://510kreport.com/device/P960058 · printed Nov 6, 2026
Cite this page
510(k) Report. “P960058: Clarion Multi-Strategy Cochlear Implant.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960058
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026