510(k) · Cleared
Recalled · 2012Soundbite Hearing System by Sonitus Medical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonitus Medical, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Jun 21, 2011 as substantially equivalent to K100649 (Sonitus Medical, Inc., 2011) and 1 other predicate after an 88-day review. Its family tree reaches back 7 generations to 1986. It has been recalled 5 times.
- Decided
- Jun 21, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- LXB
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 7 generations to K861971 (1986). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 6 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 5 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 4 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 3 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 2 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 1 generation backK100649 Soundbite Hearing System by SonitusSonitus Medical, Inc. · 2011
- This deviceK110831 Soundbite Hearing System by Sonitus MedicalSonitus Medical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −6 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −4 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −3 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −2 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −1 | K100649 | Soundbite Hearing System by Sonitus | Sonitus Medical, Inc. | 2011 | — |
| 0 (this device) | K110831 | Soundbite Hearing System by Sonitus Medical | Sonitus Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K100649 | Soundbite Hearing System by SonitusSummary page 2…in the product's labeling. Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the SoundBite Hearing System (K1 00649) and Cochlear Baha (K090720). Basis for the Submission: The basis for the submission is for an expanded Indication for Use of th… | 2011 |
| * | K090720 | Cochlear Baha BP100Summary page 2…quivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the SoundBite Hearing System (K1 00649) and Cochlear Baha (K090720). Basis for the Submission: The basis for the submission is for an expanded Indication for Use of the SoundBite Hearing System w… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2012 | Not classified | Z-1182-2012 | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
| Feb 2, 2012 | Not classified | Z-1179-2012 | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
| Feb 2, 2012 | Not classified | Z-1181-2012 | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
| Feb 2, 2012 | Not classified | Z-1183-2012 | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
| Feb 2, 2012 | Not classified | Z-1180-2012 | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 23 ancestors has a recall.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 SoundBite Hearing System is intended for patients 18 years and older with the following indications: * Patients with moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or 'SSD"). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL. " Patients with…
Read the full statement (194 words)
The SoundBite Hearing System is intended for patients 18 years and older with the following indications:
* Patients with moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or 'SSD"). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.
" Patients with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL.
Additionally, use of SoundBite is intended for patients with:
* At least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite;
* Healthy attachment to those teeth with tooth pockets limited to no more than 5mm;
* No mobile teeth;
" Bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on X-ray on the teeth on which the device will be worn.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110831 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110831: Soundbite Hearing System by Sonitus Medical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110831
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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