510(k) · Cleared
ClearedPonto Pro
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 Jul 29, 2009 as substantially equivalent to K082108 (Oticon Medical AB, 2008) and 1 other predicate after a 112-day review. Its family tree reaches back 5 generations to 1986. 18 later devices descend from it.
- Decided
- Jul 29, 2009
- Review
- 112 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K861971 (1986). 9 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 4 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 3 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 2 generations backK042017 Baha DivinoEntific Medical Systems, Inc. · 2004
- 1 generation backK082108 Obc Bone Anchored Hearing Aid SystemOticon Medical AB · 2008
- This deviceK090996 Ponto ProOticon Medical AB · 2009
- Descendant · cites it directly · 11 of its ownK103594 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 · cites it directly · 5 of its ownK100193 Otomag Bone Conduction Hearing SystemSophono, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK102199 Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1…Sophono, Inc. · 2011
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K103594Ponto Pro PowerOticon Medical AB · 2011 · cites it directly11descendants
- 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
- K100193Otomag Bone Conduction Hearing SystemSophono, Inc. · 2010 · cites it directly5descendants
- K102199Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M)Sophono, Inc. · 2011 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −4 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −3 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −2 | K042017 | Baha Divino | Entific Medical Systems, Inc. | 2004 | — |
| −1 | K082108 | Obc Bone Anchored Hearing Aid System | Oticon Medical AB | 2008 | — |
| 0 (this device) | K090996 | Ponto Pro | Oticon Medical AB | 2009 | — |
| +1 | 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 | — |
| +1 | K100193 | Otomag Bone Conduction Hearing System | Sophono, Inc. | 2010 | — |
| +2 | K102199 | Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M) | Sophono, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2025 | 1 | 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? (3)
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…t devices Oticon Medical believes that the Ponto Pro, regarding intended use, function and procedure, is substantially equivalent to the OBC cleared in 5 10(k) K082 108, has substantially equivalent fitting technology as air conduction hearing aids with digital sound processing (exempt from 5… | 2008 |
| * | K042017 | Baha DivinoSummary page 1…with digital sound processing (exempt from 5 10(k)) and has substantially equivalent accessories for direct audio input as the Baha® Divino cleared in 5 10(k) K042017. 3. Description of the Device The Ponto Pro is a bone conduction-type hearing aid. The Ponto Pro sound processor is conne… | 2004 |
| * | — | Air conduction hearing aids with digital sound processing Named without a submission number |
What descends from it? (18)
See all 183 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 23 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K103594 (Oticon Medical AB, 2011) has gone furthest, with 11 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. 2009, 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 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 for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2 and 3 kHz). * Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between…
Read the full statement (241 words)
The Ponto Pro 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 for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2 and 3 kHz).
* 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, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
The placement of a bone anchored implant is contraindicated for patients below the age of 5.
The Ponto Pro sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha® Abutment snap coupling from Cochlear BAS. In addition, the Oticon Medical abutments can be used for connection of the Baha® sound processors with snap coupling from Cochlear BAS (Baha Divino®, Baha IntensoTM, Baha Cordelle II, Baha BP100).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090996: Ponto Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090996
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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