510(k) · Cleared
ClearedPonto 3, Ponto 3 Power and Ponto 3 SuperPower
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 Sep 29, 2016 as substantially equivalent to K132775 (Oticon Medical AB, 2013) and 1 other predicate after a 105-day review. Its family tree reaches back 8 generations to 1986. 5 later devices descend from it.
- Decided
- Sep 29, 2016
- Review
- 105 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K861971 (1986). 21 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 7 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 6 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 5 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 4 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 3 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 2 generations backK103594 Ponto Pro PowerOticon Medical AB · 2011
- 1 generation backK132775 Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013
- This deviceK161671 Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB · 2016
- Descendant · cites it directly · 3 of its ownK190540 Ponto 4Oticon Medical AB · 2019
- Descendant · 2 generations on · 2 of its ownK211640 Ponto 5 MiniOticon Medical AB · 2021
- Descendant · cites it directly · 1 of its ownK213733 Ponto 5 SuperPowerOticon Medical AB · 2021
- Descendant · 2 generations on · 0 of its ownK261142 Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical AB · 2026
- Descendant · cites it directly · 0 of its ownK182116 BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas · 2018
Most influential descendants
Showing 5 of 5 · See all- K190540Ponto 4Oticon Medical AB · 2019 · cites it directly3descendants
- K211640Ponto 5 MiniOticon Medical AB · 2021 · 2 generations on2descendants
- K213733Ponto 5 SuperPowerOticon Medical AB · 2021 · cites it directly1descendant
- K261142Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical AB · 2026 · 2 generations on0descendants
- K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −7 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −5 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −4 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −3 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −2 | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| −1 | K132775 | Ponto Plus and Ponto Plus Power | Oticon Medical AB | 2013 | — |
| 0 (this device) | K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | 2016 | — |
| +1 | K190540 | Ponto 4 | Oticon Medical AB | 2019 | — |
| +2 | K211640 | Ponto 5 Mini | Oticon Medical AB | 2021 | — |
| +1 | K213733 | Ponto 5 SuperPower | Oticon Medical AB | 2021 | — |
| +2 | K261142 | Ponto 5 Mini; Ponto 5 Superpower | Oticon Medical AB | 2026 | — |
| +1 | K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | 2018 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K132775 | Ponto Plus and Ponto Plus PowerSummary page 4…codes LXB, MAH) Predicate Devices Device 510(k) no. Manufacturer Ponto Plus and Ponto Plus Power K132775 Oticon Medical AB (Primary predicate device) Baha Cordelle II K080363… | 2013 |
| * | K080363 | Baha Cordelle IISummary page 4…Ponto Plus and Ponto Plus Power K132775 Oticon Medical AB (Primary predicate device) Baha Cordelle II K080363 Cochlear BAS AB (Additional predicate device) Alta 2 (Air conduction hearing aid) Exempt from 51… | 2008 |
| * | — | Alta 2 (Air conduction hearing aid) Named without a submission number |
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?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K190540 (Oticon Medical AB, 2019) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K132775.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Intended use: The Ponto 3 sound processors are intended for improvement of hearing for patients with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single sided deafness. Indications for use: Ponto 3, Ponto 3 Power and Ponto 3 SuperPower are intended for the following patients and indications: • Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The…
Read the full statement (364 words)
Intended use:
The Ponto 3 sound processors are intended for improvement of hearing for patients with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single sided deafness.
Indications for use:
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower are 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 3 sound processor, 55 dB HL for use with the Ponto 3 Power sound processor 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.
• Indicated for 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 3, Ponto 3 Power and Ponto 3 SuperPower 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 3 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/K161671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161671: Ponto 3, Ponto 3 Power and Ponto 3 SuperPower.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161671
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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