510(k) · Cleared
ClearedBaha Intenso
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cochlear Americas · LXB Hearing Aid, Bone Conduction
Cleared on Aug 28, 2008 as substantially equivalent to K042017 (Entific Medical Systems, Inc., 2004) after an 83-day review. Its family tree reaches back 4 generations to 1986. 35 later devices descend from it.
- Decided
- Aug 28, 2008
- Review
- 83 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K861971 (1986). 8 ancestors in all. 35 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 3 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 2 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 1 generation backK042017 Baha DivinoEntific Medical Systems, Inc. · 2004
- This deviceK081606 Baha IntensoCochlear Americas · 2008
- Descendant · cites it directly · 33 of its ownK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- Descendant · 2 generations on · 11 of its ownK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- Descendant · cites it directly · 11 of its ownK103594 Ponto Pro PowerOticon Medical AB · 2011
- Descendant · 3 generations on · 10 of its ownK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- Descendant · 2 generations on · 10 of its ownK132775 Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009 · cites it directly33descendants
- K132278Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013 · 2 generations on11descendants
- K103594Ponto Pro PowerOticon Medical AB · 2011 · cites it directly11descendants
- K142907Baha 5 Sound ProcessorCochlear Americas · 2015 · 3 generations on10descendants
- K132775Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −3 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −2 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −1 | K042017 | Baha Divino | Entific Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K081606 | Baha Intenso | Cochlear Americas | 2008 | — |
| +1 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| +2 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| +1 | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| +3 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
| +2 | K132775 | Ponto Plus and Ponto Plus Power | Oticon Medical AB | 2013 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K042017 | Baha DivinoSummary page 2…vices The design, manufacturing, function and fitting procedure of the Baha IntensoTM have not changed since it was marketed in 2007 using a Letter To file under 510(k) K042017 (Baha Divino). This submission is intended only for an expanded Indications For Use for this sound processor. The proposed expand… | 2004 |
What descends from it? (35)
See all 353 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 22 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K090720 (Cochlear Bone Anchored Systems AB, 2009) has gone furthest, with 33 descendants of its own.
- 4 other devices also cite its predicate K042017.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Baha IntensoTM sound processor is intended for use with the Baha auditory osseointegrated implant or Baha Headband for the following patients and indications: * Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1,2, and 3 kHz) should be better than or equal to 55 dB HL. * Bilateral fitting of the Intenso is intended for…
Read the full statement (216 words)
The Baha IntensoTM sound processor is intended for use with the Baha auditory osseointegrated implant or Baha Headband for the following patients and indications:
* Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1,2, and 3 kHz) should be better than or equal to 55 dB HL.
* Bilateral fitting of the Intenso is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
* Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. single-sided deafness or "SSD"). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
* Baha for SSD is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081606 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081606: Baha Intenso.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081606
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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