510(k) · Cleared
ClearedPonto 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 Sep 7, 2012 as substantially equivalent to K112053 (Oticon Medical AB, 2011) and 1 other predicate after a 137-day review. Its family tree reaches back 6 generations to 1986. 4 later devices descend from it.
- Decided
- Sep 7, 2012
- Review
- 137 days
- Class
- Class II
- Product code
- MAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K861971 (1986). 18 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 5 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 4 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 3 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 2 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 1 generation backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- This deviceK121228 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 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −6 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −5 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −3 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −2 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −1 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112053 | Obc Bone Anchored Hearing SystemSummary page 1…ed Classification regulation: 21 C.F.R. 874.3300 Product Code: MAH Predicate Devices Ponto bone anchored hearing system (K112053). Oticon Medical AB Cochlear Baha BP100 (K090720) Cochlear BAS Intended Use The Ponto bo… | 2011 |
| * | K090720 | Cochlear Baha BP100Summary page 1…3300 Product Code: MAH Predicate Devices Ponto bone anchored hearing system (K112053). Oticon Medical AB Cochlear Baha BP100 (K090720) Cochlear BAS Intended Use The Ponto bone anchored hearing system is intended for improvement of hea… | 2009 |
What descends from it? (4)
2 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?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K142678 (Oticon Medical AB, 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K112053.
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. 2012, 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 system (sound processors Ponto, Ponto Pro and Ponto Pro Power and 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…
Read the full statement (314 words)
The Ponto bone anchored hearing system (sound processors Ponto, Ponto Pro and Ponto Pro Power and 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 dB HL 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 dB 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 "SS0"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20dcB HL (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 CR05) hearing aid, but who for some reason cannot or will not use an AC CR05.
The placement of a bone anchored implant is contraindicated for patient below the age of 5.
The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121228: Ponto Bone Anchored Hearing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121228
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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