510(k) · Cleared
ClearedPonto Bone Anchored Hearing System, MONO Surgery Kit
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 Mar 3, 2021 as substantially equivalent to K152067 (Oticon Medical AB, 2015) after a 65-day review. Its family tree reaches back 10 generations to 1986.
- Decided
- Mar 3, 2021
- Review
- 65 days
- Class
- Class II
- Product code
- MAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K861971 (1986). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 6 generations between
- 3 generations backK132775 Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013
- 2 generations backK142678 Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone…Oticon Medical AB · 2015
- 1 generation backK152067 Ponto bone anchored hearing systemOticon Medical AB · 2015
- This deviceK203807 Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB · 2021
Show all 10 generations
- Root · 10 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 9 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 8 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 7 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 6 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 5 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 4 generations backK103594 Ponto Pro PowerOticon Medical AB · 2011
- 3 generations backK132775 Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013
- 2 generations backK142678 Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone…Oticon Medical AB · 2015
- 1 generation backK152067 Ponto bone anchored hearing systemOticon Medical AB · 2015
- This deviceK203807 Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −9 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −7 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −6 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −5 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −4 | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| −3 | K132775 | Ponto Plus and Ponto Plus Power | Oticon Medical AB | 2013 | — |
| −2 | 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 | — |
| 0 (this device) | K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | 2021 | — |
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 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K152067 | Ponto bone anchored hearing systemSummary page 5…ss: 21 CFR §874.3300, Class II Product Code: MAH Predicate Devices Predicate Device 510(k) no. Manufacturer Ponto Bone Anchored Hearing K152067 Oticon Medical AB System Device Description and purpose of the 510(k) notice The Ponto Bone Anchored Hearing System… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 25 ancestors has a recall.
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. 2021, 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 (Ponto sound processors and implant system) is intended for the following patients and indications: • Patients 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 3 and Ponto 4 sound processors…
Read the full statement (323 words)
The Ponto Bone Anchored Hearing System (Ponto sound processors and implant system) is intended for the following patients and indications:
• Patients 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 3 and Ponto 4 sound processors, 55 dB HL for use with the Ponto 3 Power sound processors and 65 dB HL for use with the Ponto 3 SuperPower 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 “SSD”). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB 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 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.
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/K203807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203807: Ponto Bone Anchored Hearing System, MONO Surgery Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203807
Report an extraction error
Are you the manufacturer?
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