510(k) · Cleared
ClearedObc Bone Anchored Hearing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oticon Medical AB · MAH Hearing Aid, Bone Conduction, Implanted
Cleared on Nov 18, 2011 after a 122-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 122 days
- Class
- Class II
- Product code
- MAH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK112053 Obc Bone Anchored Hearing SystemOticon Medical AB · 2011
- Descendant · cites it directly · 4 of its ownK121228 Ponto Bone Anchored Hearing SystemOticon Medical AB · 2012
- Descendant · cites it directly · 3 of its ownK142678 Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone…Oticon Medical AB · 2015
- Descendant · cites it directly · 1 of its ownK152067 Ponto bone anchored hearing systemOticon Medical AB · 2015
- Descendant · 2 generations on · 0 of its ownK203807 Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB · 2021
- Descendant · 2 generations on · 0 of its ownK152820 Ponto Bone Anchored Hearing SystemOticon Medical AB · 2016
Most influential descendants
Showing 5 of 5 · See all- K121228Ponto Bone Anchored Hearing SystemOticon Medical AB · 2012 · cites it directly4descendants
- K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System /…Oticon Medical AB · 2015 · cites it directly3descendants
- K152067Ponto bone anchored hearing systemOticon Medical AB · 2015 · cites it directly1descendant
- K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB · 2021 · 2 generations on0descendants
- K152820Ponto Bone Anchored Hearing SystemOticon Medical AB · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112053 | Obc Bone Anchored Hearing System | Oticon Medical AB | 2011 | — |
| +1 | K121228 | Ponto Bone Anchored Hearing System | Oticon Medical AB | 2012 | — |
| +1 | K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored… | Oticon Medical AB | 2015 | — |
| +1 | K152067 | Ponto bone anchored hearing system | Oticon Medical AB | 2015 | — |
| +2 | K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | 2021 | — |
| +2 | K152820 | Ponto Bone Anchored Hearing System | Oticon Medical AB | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAH device
- #1 K261142 Ponto 5 Mini; Ponto 5 Superpowerscore 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121228 (Oticon Medical AB, 2012) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MAH devicesMAH Hearing Aid, Bone Conduction, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MAH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MAH
124in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAH
No recall names MAH since 2007.
Adverse event reports per year · MAH
562in 2025
MAUDE reports naming product code MAH, 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 | 0 | — | 0 | 9 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 46 |
| 2015 | 3 | 124 | 0 | 52 |
| 2016 | 1 | — | 0 | 309 |
| 2017 | 0 | — | 0 | 614 |
| 2018 | 1 | — | 0 | 629 |
| 2019 | 0 | — | 0 | 635 |
| 2020 | 0 | — | 0 | 692 |
| 2021 | 1 | — | 0 | 709 |
| 2022 | 0 | — | 0 | 711 |
| 2023 | 0 | — | 0 | 742 |
| 2024 | 0 | — | 0 | 621 |
| 2025 | 0 | — | 0 | 562 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ponto bone anchored hearing implant system is intended for the following patients and indications; Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto and Ponto Pro sound processors, 55 dIB HE for use with the Ponto Pro…
Read the full statement (237 words)
The Ponto bone anchored hearing implant system is intended for the following patients and indications;
Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto and Ponto Pro sound processors, 55 dIB HE for use with the Ponto Pro Power sound processor.
Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dlB at individual frequencies.
Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dlB HE (measured at 0.5, 1, 2 and 3 kHz).
Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
The placement of a bone anchored implant is contraindicated for patient below the age of 5.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112053 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112053: Obc Bone Anchored Hearing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112053
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026