510(k) · Cleared
ClearedBaha Divino
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entific Medical Systems, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Aug 26, 2004 as substantially equivalent to K955713 (Nobelpharma USA, Inc., 1996) and 3 other predicates after a 30-day review. Its family tree reaches back 3 generations to 1986. 39 later devices descend from it.
- Decided
- Aug 26, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K861971 (1986). 7 ancestors in all. 39 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 2 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 1 generation backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- This deviceK042017 Baha DivinoEntific Medical Systems, Inc. · 2004
- Descendant · cites it directly · 35 of its ownK081606 Baha IntensoCochlear Americas · 2008
- Descendant · cites it directly · 33 of its ownK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- Descendant · cites it directly · 19 of its ownK082108 Obc Bone Anchored Hearing Aid SystemOticon Medical AB · 2008
- Descendant · cites it directly · 18 of its ownK090996 Ponto ProOticon Medical AB · 2009
- Descendant · 2 generations on · 11 of its ownK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K081606Baha IntensoCochlear Americas · 2008 · cites it directly35descendants
- K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009 · cites it directly33descendants
- K082108Obc Bone Anchored Hearing Aid SystemOticon Medical AB · 2008 · cites it directly19descendants
- K090996Ponto ProOticon Medical AB · 2009 · cites it directly18descendants
- K132278Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −2 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −1 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| 0 (this device) | K042017 | Baha Divino | Entific Medical Systems, Inc. | 2004 | — |
| +1 | K081606 | Baha Intenso | Cochlear Americas | 2008 | — |
| +1 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| +1 | K082108 | Obc Bone Anchored Hearing Aid System | Oticon Medical AB | 2008 | — |
| +1 | K090996 | Ponto Pro | Oticon Medical AB | 2009 | — |
| +2 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K955713 | Nobelpharma Bone Anchored Hearing AidSummary page 1…sound processing (exempt from 5 10(k)) and, regarding intended use, function and fitting procedure, is equivalent to previous models of BAHA cleared in 510(k) K955713, K984162, KOl1 143 8 and K0218 37. 3. Description of the Device The BAHA Divino is a bone conduction-type hearing ai… | 1996 |
| * | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseSummary page 1…ocessing (exempt from 5 10(k)) and, regarding intended use, function and fitting procedure, is equivalent to previous models of BAHA cleared in 510(k) K955713, K984162, KOl1 143 8 and K0218 37. 3. Description of the Device The BAHA Divino is a bone conduction-type hearing aid. Unlike… | 1999 |
| * | K011438 | Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System. | 2001 |
| * | K021837 | Branenmark Bone-Anchored-Hearing Aid (Baha)Summary page 1…10(k)) and, regarding intended use, function and fitting procedure, is equivalent to previous models of BAHA cleared in 510(k) K955713, K984162, KOl1 143 8 and K0218 37. 3. Description of the Device The BAHA Divino is a bone conduction-type hearing aid. Unlike conventional hearing aid… | 2002 |
| * | — | Air conduction hearing aids with digital sound processing Named without a submission number |
What descends from it? (39)
See all 395 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 18 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K081606 (Cochlear Americas, 2008) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K955713.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Divino is intended 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 threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz) - Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses.…
Read the full statement (187 words)
The BAHA Divino is intended 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 threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)
- Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies
- The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz
BAHA for SSD is also indicated for patients who are indicated for an AC CROS 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/K042017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042017: Baha Divino.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042017
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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