510(k) · Cleared
ClearedCochlear Baha SoundArc
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 Jun 7, 2017 as substantially equivalent to K002913 (Entific Medical Systems, Inc., 2000) and 7 other predicates after a 56-day review. Its family tree reaches back 9 generations to 1986.
- Decided
- Jun 7, 2017
- Review
- 56 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 9 generations to K861971 (1986). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 5 generations between
- 3 generations backK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- 2 generations backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- 1 generation backK153245 Baha 5 Super Power Sound ProcessorCochlear Americas · 2016
- This deviceK171088 Cochlear Baha SoundArcCochlear Americas · 2017
Show all 9 generations
- Root · 9 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 8 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 7 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 6 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 5 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 4 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 3 generations backK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- 2 generations backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- 1 generation backK153245 Baha 5 Super Power Sound ProcessorCochlear Americas · 2016
- This deviceK171088 Cochlear Baha SoundArcCochlear Americas · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −8 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −6 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −5 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −4 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −3 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| −2 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
| −1 | K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | 2016 | — |
| 0 (this device) | K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017 | — |
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 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (8)
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 |
|---|---|---|---|
| * | K002913 | Headband for BahaSummary page 4…R §874.3300 Product Codes: LXB Panel: Ear Nose and Throat Devices Panel Primary System Predicate Baha headband/Softband, K002913 Secondary System Predicates: Sound Processors of the Baha system: K080363, K090720, K110996, K… | 2000 |
| * | K080363 | Baha Cordelle IISummary page 4…Ear Nose and Throat Devices Panel Primary System Predicate Baha headband/Softband, K002913 Secondary System Predicates: Sound Processors of the Baha system: K080363, K090720, K110996, K132278, K142907, K153245, K161123 K171088 F. Purpose of Subm… | 2008 |
| * | K090720 | Cochlear Baha BP100Summary page 4…se and Throat Devices Panel Primary System Predicate Baha headband/Softband, K002913 Secondary System Predicates: Sound Processors of the Baha system: K080363, K090720, K110996, K132278, K142907, K153245, K161123 K171088 F. Purpose of Submission Th… | 2009 |
| * | K110996 | Baha 3 Power Sound ProcessorSummary page 4…m Predicate Baha headband/Softband, K002913 Secondary System Predicates: Sound Processors of the Baha system: K080363, K090720, K110996, K132278, K142907, K153245, K161123 K171088 F. Purpose of Submission The purpose of this Special 510(k) is to in… | 2011 |
| * | K132278 | Cochlear Baha 4 Sound ProcessorSummary page 4…te Baha headband/Softband, K002913 Secondary System Predicates: Sound Processors of the Baha system: K080363, K090720, K110996, K132278, K142907, K153245, K161123 K171088 F. Purpose of Submission The purpose of this Special 510(k) is to introduce a… | 2013 |
| * | K142907 | Baha 5 Sound ProcessorSummary page 4…Baha headband/Softband, K002913 Secondary System Predicates: Sound Processors of the Baha system: K080363, K090720, K110996, K132278, K142907, K153245, K161123 K171088 F. Purpose of Submission The purpose of this Special 510(k) is to introduce a new styl… | 2015 |
| * | K153245 | Baha 5 Super Power Sound ProcessorSummary page 4…dband/Softband, K002913 Secondary System Predicates: Sound Processors of the Baha system: K080363, K090720, K110996, K132278, K142907, K153245, K161123 K171088 F. Purpose of Submission The purpose of this Special 510(k) is to introduce a new style of head… | 2016 |
| * | K161123 | Baha 5 Power Sound ProcessorSummary page 4…tband, K002913 Secondary System Predicates: Sound Processors of the Baha system: K080363, K090720, K110996, K132278, K142907, K153245, K161123 K171088 F. Purpose of Submission The purpose of this Special 510(k) is to introduce a new style of headband, kno… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 25 ancestors have a recall of any class.
- 1 other device also cites its predicate K002913.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Cochlear Baha® SoundArc is intended for test situations and for patients who cannot or choose not to have an implant for the following indications for use: • Patients of any age 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 3kHz) should be better than or equal to 45 dB HL for use with the BP100, Baha 4 and Baha 5 sound…
Read the full statement (265 words)
The Cochlear Baha® SoundArc is intended for test situations and for patients who cannot or choose not to have an implant for the following indications for use:
• Patients of any age 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 3kHz) should be better than or equal to 45 dB HL for use with the BP100, Baha 4 and Baha 5 sound processors, 55 dB HL for use with the BP110 Power and Baha 5 Power sound processors, and better than or equal to 65 dB HL for use with the Cordelle II and Baha 5 SuperPower Sound Processors.
• Bilateral fitting 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-conductive 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 15dB 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: SSDTM). 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/K171088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171088: Cochlear Baha SoundArc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171088
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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