510(k) · Cleared
ClearedPonto Pro Power
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oticon Medical AB · LXB Hearing Aid, Bone Conduction
Cleared on Jun 15, 2011 as substantially equivalent to K082108 (Oticon Medical AB, 2008) and 3 other predicates after a 189-day review. Its family tree reaches back 6 generations to 1986. 11 later devices descend from it.
- Decided
- Jun 15, 2011
- Review
- 189 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K861971 (1986). 19 ancestors in all. 11 later devices descend from it, 1 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 deviceK103594 Ponto Pro PowerOticon Medical AB · 2011
- Descendant · cites it directly · 10 of its ownK132775 Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013
- Descendant · 2 generations on · 5 of its ownK161671 Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB · 2016
- Descendant · 3 generations on · 3 of its ownK190540 Ponto 4Oticon Medical AB · 2019
- Descendant · 2 generations on · 3 of its ownK142678 Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone…Oticon Medical AB · 2015
- Descendant · 4 generations on · 2 of its ownK211640 Ponto 5 MiniOticon Medical AB · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132775Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013 · cites it directly10descendants
- K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB · 2016 · 2 generations on5descendants
- K190540Ponto 4Oticon Medical AB · 2019 · 3 generations on3descendants
- K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System /…Oticon Medical AB · 2015 · 2 generations on3descendants
- K211640Ponto 5 MiniOticon Medical AB · 2021 · 4 generations on2descendants
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) | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| +1 | K132775 | Ponto Plus and Ponto Plus Power | Oticon Medical AB | 2013 | — |
| +2 | K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | 2016 | — |
| +3 | K190540 | Ponto 4 | Oticon Medical AB | 2019 | — |
| +2 | K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored… | Oticon Medical AB | 2015 | — |
| +4 | K211640 | Ponto 5 Mini | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2026 | 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 LXB? 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 LXB device
- #1 K254296 Ossiclear (Ossiclear System)score 14.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K082108 | Obc Bone Anchored Hearing Aid SystemSummary page 1…ical believes that the Ponto Pro Power, regarding intended use, function, procedure and fitting, is substantially equivalent to the Ponto and Ponto Pro cleared in K082 108 and K090996. The indications for use are equivalent to the Baha® lntenSoTM cleared in K08 1606. The ability to measure… | 2008 |
| * | K090996 | Ponto ProSummary page 1…that the Ponto Pro Power, regarding intended use, function, procedure and fitting, is substantially equivalent to the Ponto and Ponto Pro cleared in K082 108 and K090996. The indications for use are equivalent to the Baha® lntenSoTM cleared in K08 1606. The ability to measure bone-con… | 2009 |
| * | K090720 | Cochlear Baha BP100Summary page 1…bone-conduction thresholds directly via pure tones generated by the sound processor (BC In-Situ Audiometry), is substantially equivalent to the Baha® BPIOO0 in K090720. 3. Description of the device Ponto Pro Power is a bone conduction hearing aid which is connected to an implan… | 2009 |
| * | K081606 | Baha IntensoSummary page 1…, is substantially equivalent to the Ponto and Ponto Pro cleared in K082 108 and K090996. The indications for use are equivalent to the Baha® lntenSoTM cleared in K08 1606. The ability to measure bone-conduction thresholds directly via pure tones generated by the sound processor (BC In-Situ… | 2008 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132775 | Ponto Plus and Ponto Plus Power | 2013 | 10 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K132775 (Oticon Medical AB, 2013) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K082108.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LXB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LXB
79in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LXB
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXB
261in 2025
MAUDE reports naming product code LXB, 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 | 4 |
| 2008 | 2 | — | 0 | 110 |
| 2009 | 2 | — | 0 | 76 |
| 2010 | 2 | — | 0 | 91 |
| 2011 | 5 | 189 | 0 | 123 |
| 2012 | 1 | — | 5 | 346 |
| 2013 | 5 | 103 | 0 | 640 |
| 2014 | 0 | — | 0 | 545 |
| 2015 | 2 | — | 0 | 824 |
| 2016 | 4 | 110 | 0 | 692 |
| 2017 | 1 | — | 0 | 379 |
| 2018 | 1 | — | 1 | 336 |
| 2019 | 1 | — | 0 | 497 |
| 2020 | 0 | — | 0 | 547 |
| 2021 | 4 | 79 | 0 | 490 |
| 2022 | 0 | — | 0 | 387 |
| 2023 | 0 | — | 0 | 348 |
| 2024 | 0 | — | 0 | 232 |
| 2025 | 2 | — | 0 | 261 |
| 2026 | 4 | 164 | 0 | — |
What is it indicated for?
The Ponto Pro Power 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 of the indicated ear should be better than or equal to 55 dB HL (measured at 0.5, 1, 2 and 3 kHz). Bilateral fitting is applicable for patients having a symmetrically conductive or mixed hearing loss. The difference…
Read the full statement (248 words)
The Ponto Pro Power 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 of the indicated ear should be better than or equal to 55 dB HL (measured at 0.5, 1, 2 and 3 kHz).
Bilateral fitting is applicable for 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 Pro Power sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha® Abutment snap coupling from Cochlear Bone Anchored Solutions AB (ref no. 90410, 90305, 90434, 90480).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103594 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103594: Ponto Pro Power.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103594
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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