(267 days)
No
The device description and intended use clearly describe a passive mechanical prosthesis for sound transmission. There is no mention of any computational or analytical functions that would involve AI or ML.
Yes
The device is described as a 'stapesplasty prosthesis' intended to replace ossicles and restore sound transmission in the middle ear, thereby treating conductive hearing loss caused by various conditions. This functional restoration to treat a medical condition aligns with the definition of a therapeutic device.
No
This device is a prosthesis intended to replace damaged ossicles in the middle ear to restore sound transmission. It is a treatment device, not one used for diagnosis.
No
The device description clearly states it is a "passive middle ear implant – stapesplasty prosthesis" and describes it as a physical object ("partial ossicular replacement prostheses") that is implanted. This indicates it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a passive middle ear implant used for the physical replacement of ossicles to restore sound transmission. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The description details a physical prosthesis implanted in the middle ear.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.
The stapesplasty prosthesis is indicated to treat patients with:
- congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear
- inadequate conductive hearing from previous stapes surgery
Product codes
ETB
Device Description
The MED-EL "Passive Middle Ear Implants" (PMEls) Stapesplasty Prostheses are partial ossicular replacement prostheses which restore the mechanical sound transmission to the oval window. A partial (stapedotomy) or total opening of the footplate (stapedectomy) is required. The distal end (=piston) of the device is placed into the opening of the inner ear. The other end of the prosthesis (=Loop or Clip) is coupled to the long process of the incus or to the handle of the malleus.
They are offered in different designs, functional lengths and/or piston diameters to allow the surgeon to have more flexibility in terms of selecting the correct prosthesis according to the individual patient's anatomical needs, and the surgeon's surgical preferences and proficiency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Middle ear
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
Qualified ENT surgeons only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test:
Non-clinical testing was conducted to assess the performance data for a determination of substantial equivalence.
The following tests were conducted:
-
MRI environment according to ASTM F2119, F2052, F2182 с MRI Conditional at 1.5T, 3.0T and 7.0T
-
Biocompatibility according to EN ISO 10993. The performed evaluation provides objective evidence to support the conclusion that the devices can be considered biocompatible for their intended use.
-
Shelf-Life testing according to EN ISO 11607
-
Sterilization Validation according to EN ISO 11137-1, EN ISO 11137-2. Gamma Sterilization with a confidence sterility assurance level of 10 dB HL: 9/168 patients = 5.4 % (range 11.3-21.3 dB HL)
-
Adverse events:
- Number of analyzed patients: 188 (127 female, 61 male)
- Age: mean 47 ± 13 years (range 12-82)
- Implanted ear: 98 right, 90 left
- Follow-up: median 179.0 days (mean 246.4 ± 212.8; range 7-709 days)
- Prosthesis type: 93 mAXIS, 64 mLOOP, 11 mZAM, 20 mFIX
- Number of revision surgeries: 0 (2 recommended)
- Number of device dislocations/extrusions: 0
- Total 16 AEs in 13 patients: 7 Device unrelated AEs, 2 Medical related AEs, 2 Clinical/surgical related AEs, 5 AEs "unknown", 0 Follow-up AE
In the above mentioned PMCF investigation the safety and effectiveness of the PMEI Stapesplasty Prostheses was confirmed as demonstrated by postoperative PTA4 ABG 10 dB HL: 9/168 patients = 5.4 % (range 11.3-21.3 dB HL)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2025
Med-El Elektromedizinische Geräte GmbH Inés Román Santiago Senior Regulatory Affairs Fürstenweg 77a Innsbruck, Tirol 6020 Austria
Re: K241142
Trade/Device Name: mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: December 19, 2024 Received: December 19, 2024
Dear Inés Román Santiago:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce C. Lin-S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241142
Device Name
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis.
Indications for Use (Describe) INTENDED USE:
INTENDED USE.
The passive middle ear impl
The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.
INTENDED USER
The stapesplasty prosthesis is intended to be implanted by qualified ENT surgeons only, with adequate skills to perform otological surgeries. Replacement of the ossicular chain is a standard surgical procedure, no additional specific device training is mandatory or required for the safe and effective use.
TARGET PATIENT POPULATION
The target patient population for the passive middle ear implant are patients of all ages requiring reconstruction of the ossicular chain.
INDICATIONS:
The stapesplasty prosthesis is indicated to treat patients with:
-
congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear
-
inadequate conductive hearing from previous stapes surgery
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/5/Picture/0 description: The image shows the logo for MED-EL, a company that specializes in hearing implants. The logo is in red and features the company name in bold, sans-serif font. To the right of the letters "D" and "E" is a circular graphic with curved lines, possibly representing an ear or sound waves. The overall design is simple and modern.
510(k) SUMMARY of Safety and Effectiveness MED-EL Elektromedizinische Geräte GmbH [As Required by 21 CFR 807.92(c)]
Submitter [807.92(a)(1)] 1.0
Manufacturer: MED-EL Elektromedizinische Geräte GmbH (hereafter MED-EL) Fürstenweg 77a, 6020 Innsbruck Austria
Contact Person:
Ines Roman Santiago MED-EL Regulatory Affairs Senior Specialist Phone: +43 577885786 E-Mail: ines.romansantiago@medel.com
FDA Official Correspondent: Elizabeth Gfoeller MED-EL Corporate Director, Regulatory Affairs Phone: +43 577885614 E-Mail: elizabeth.gfoeller@medel.com
Date the Summary was prepared: 17th January 2025.
Device Names [807.92(a)(2)] 2.0
Table 1 Device/Trade Names of MED-EL PMEI Stapesplasty Prostheses
| Device/Trade
Name | Generic category
& Medical Specialty | Classification | Product
code | Regulation
(CFR) |
|----------------------------|-------------------------------------------------------------------------------------------------------|----------------|-----------------|---------------------|
| mAXIS Stapes
Prosthesis | Middle ear, Prosthesis,
Partial Ossicular
Replacement Prostheses
(Ear, Nose & Throat) | Class II | ETB | 874.3450 |
| mLOOP Stapes
Prosthesis | | | | |
| mZAM Stapes
Prosthesis | | | | |
| mFIX Stapes
Prosthesis | | | | |
6
Image /page/6/Picture/0 description: The image shows the MED-EL logo in red. The logo consists of the word "MED" followed by a stylized image of a cochlea, and then the letters "EL". The cochlea image is a red circle with a white swirl inside.
3.0 Predicate Devices [807.92(a)(3)]
| MED-EL device | Primary Predicate Device A | Predicate Device B |
|---|---|---|
| mAXIS Stapes Prosthesis | N/A | |
| mLOOP Stapes Prosthesis | Kurz K-Piston | |
| K002221 | ||
| mZAM Stapes Prosthesis | Detroit Piston | |
| K130512 | Skarzynski | |
| Piston | ||
| K130512 | ||
| mFIX Stapes Prosthesis | Clip Piston | |
| àWengen | ||
| K021479 |
Table 2 Predicate devices manufactured by Heinz Kurz GmbH
Description of the Devices [807.92(a)(4)] 4.0
The MED-EL "Passive Middle Ear Implants" (PMEls) Stapesplasty Prostheses are partial ossicular replacement prostheses which restore the mechanical sound transmission to the oval window. A partial (stapedotomy) or total opening of the footplate (stapedectomy) is required. The distal end (=piston) of the device is placed into the opening of the inner ear. The other end of the prosthesis (=Loop or Clip) is coupled to the long process of the incus or to the handle of the malleus.
They are offered in different designs, functional lengths and/or piston diameters to allow the surgeon to have more flexibility in terms of selecting the correct prosthesis according to the individual patient's anatomical needs, and the surgeon's surgical preferences and proficiency.
| Device/Trade
| Name | mAXIS | mLOOP | mZAM | mFIX |
|---|---|---|---|---|
| Stapesplasty Prosthesis | ||||
| Design | Image: MAXIS design | Image: mLOOP design | Image: mZAM design | Image: mFIX design |
| Spiral-shaped loop for easier application | Clip for standardized coupling | |||
| Coupling | ||||
| structure | Loop band width = | |||
| 0.5mm | ||||
| (broad & | ||||
| perforated loop) | Loop band width | |||
| = 0.3mm | Loop band width | |||
| = 0.20mm | Clip band width | |||
| =0.2mm | ||||
| Material | Medical grade titanium | |||
| Method of | ||||
| Attachment | Manually, with crimping | Manually, with | ||
| clipping | ||||
| Sterile / | ||||
| Single-Use | Yes |
Table 3 Description of the MED-EL PMEI Stapesplasty
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Image /page/7/Picture/0 description: The image shows the logo for MED-EL, a company that specializes in hearing implants. The logo is in red and features the company name in bold letters. To the right of the letters "MED" is a circular graphic with curved lines inside.
5.0 Statement of the Intended use [807.92(a)(5)]
The intended use and indications of the MED-EL PMEI Stapesplasty Prostheses and of the predicate device(s) manufactured by Heinz Kurz GmbH are substantially equivalent. Comparing the subject devices and the respective predicate devices, the same medical conditions or underlying pathologies can be treated, and the principal functionality of the devices is the same, hence no different questions of safety and effectiveness arise.
PMEI Stapesplasty Prostheses
Intended Use
The passive middle ear implant - stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.
Intended User
The stapesplasty prosthesis is intended to be implanted by qualified ENT surgeons only, with adequate skills to perform otological surgeries. Replacement of the ossicular chain is a standard surgical procedure, no additional specific device training is mandatory or required for the safe and effective use.
Target Patient Population
The target patient population for the passive middle ear implant are patients of all ages requiring reconstruction of the ossicular chain.
Indications:
The stapesplasty prosthesis is indicated to treat patients with:
- congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear.
- inadequate conductive hearing from previous stapes surgery.
8
Image /page/8/Picture/0 description: The image shows the logo for MED-EL, a company that specializes in hearing implants. The logo is in red and features the company name in bold letters. The "O" in MED-EL is replaced with a stylized ear symbol. The logo is simple and modern, and it effectively communicates the company's focus on hearing solutions.
6.0 Comparison on Technological Characteristics with predicate devices [807.92(a)(6)]
The MED-EL PMEIs have the same technological characteristics (i.e. design, material, chemical composition, etc.) as the predicate devices identified in paragraph (a)|3). Hence, no difference in safety and effectiveness of the MED-EL PME! Stapesplasty Prostheses as compared to the predicate device(s) from Heinz Kurz GmbH is expected. A summary of the technological characteristics is provided in the following table.
6.1 PMEI Stapesplasty Prostheses – Comparison with predicate devices
| MED-EL Device /
Predicate Device | "mAXIS Stapes
Prosthesis" | Predicate
Device [A]
"Detroit
Piston"
(K130512) | "mLOOP
Stapes
Prosthesis" | Predicate
Device [B]
"K-Piston"
(K002221) | "mZAM Stapes
Prosthesis" | Predicate
Device [B]
"Skarzynski
Piston"
(K130512) | "mFIX Stapes
Prosthesis" | Predicate
Device [B]
"Clip Piston
àWengen"
(K021479) |
|-------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Design | Image: mAXIS Stapes Prosthesis | Image: Detroit Piston | Image: mLOOP Stapes Prosthesis | Image: K-Piston | Image: mZAM Stapes Prosthesis | Image: Skarzynski Piston | Image: mFIX Stapes Prosthesis | Image: Clip Piston àWengen |
| | Broad, perforated & spiral-
shaped loop | | Spiral-shaped loop | | Narrow band & spiral-shaped
loop | | Clip-type coupling structure | |
| Attachment | Manually, with crimping | | | | | Manually, without crimping | | |
| # of sizes | 27 | 24 | 28 | | 27 | 16 | 18 | 16 |
| Piston Ø [mm] | 0.4 / 0.5 / 0.6 | | 0.4 / 0.6 | | 0.4 / 0.5 / 0.6 | 0.4 / 0.6 | 0.4 / 0.6 | |
| Functional lengths
[mm] | 3.5, 3.75, 4.0,
4.25, 4.5, 4.75,
5.0, 5.25 , 5.5 | 3.5, 3.75, 4.0,
4.25, 4.5,
4.75, 5.0, 5.5 | 3.5, 3.75, 4.0, 4.25, 4.5, 4.75,
5.0, 5.25, 5.5, 6.0, 7.0, 8.0, 9.0,
10.0 | | 3.5, 3.75, 4.0,
4.25, 4.5,
4.75, 5.0,
5.25 , 5.5 | 3.5, 3.75, 4.0,
4.25, 4.5,
4.75, 5.0, 5.5 | 3.5, 3.75, 4.0,
4.25, 4.5,
4.75, 5.0,
5.25 , 5.5 | 3.5, 3.75, 4.0,
4.25, 4.5, 4.75,
5.0, 5.5 |
| Loop width [mm] | 0.50 | | | 0.30 | 0.20 | 0.25 | 0.20 | 0.25 |
Table 4: PMEI Stapesplasty Prostheses - Comparison of Technical Characteristics
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Image /page/9/Picture/0 description: The image shows the logo for MED-EL, a company that specializes in hearing implants. The logo is in red and features the company name in a bold, sans-serif font. The "O" in MED-EL is replaced with a stylized ear symbol.
| Materials | Medical grade titanium ASTM F67 | Medical grade
titanium ASTM
F136 (clip) and
ASTM F67
(shaft, piston) | Medical grade
titanium ASTM
F67 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------|
| Biocompatible | Yes (EN ISO 10993) | | |
| Surgical Tools
(mandatory) | N/A | | |
| Surgical tools
(optional) | MED-EL does not offer any optional surgical tool for the PMEI Stapesplasty Prosthesis.
The manufacturer of the predicate device(s) offers the "KURZ-Meter" as an optional surgical tool. | | |
| Packaging | One length/diameter-variant per package; Single-Use; Sterile | | |
| MRI | MRI Conditional at 1.5, 3.0 and 7.0 T | | |
Comparing the MED-EL PMEI Stapesplasty Prostheses and their identified predicated by Heinz Kurz GmbH, the method of attachment, biocompatibility, packaging configuration and MRI compatibility are IDENTICAL.
The following features are considered EQUIALENT: device design, number and dimensions of length/diameter variants, materials in body contact. As there is no difference in technological characteristics, there is no difference in safety and/or effectiveness.
There is just one difference: the surgical tools. For intraoperative measuring of the required prosthesis length, Heinz Kurz GmbH provides the KURZ-Meter however MED-EL does not provide such a tool due to other optional surgical tools are available on the market that can be used to determine the required prosthesis length to be used during a well-established stapes replacement surgical procedure. Thus, as there is no difference in technological characteristics, there is no difference in safety and effectiveness of the MED-EL PMEI Stapesplasty Prostheses compared to the predicate devices from Heinz Kurz GmbH is expected.
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Image /page/10/Picture/0 description: The image shows the logo for MED-EL, a company that specializes in hearing implants. The logo is in red and features the company name in bold, sans-serif font. To the right of the name is a stylized graphic of an ear, also in red. The logo is simple and modern, and the use of red conveys a sense of energy and innovation.
7.0 Non-clinical Test [807.92(b)(1)]
Non-clinical testing was conducted to assess the performance data for a determination of substantial equivalence.
The following tests were conducted:
- . MRI environment according to ASTM F2119, F2052, F2182 с MRI Conditional at 1.5T, 3.0T and 7.0T
- . Biocompatibility according to EN ISO 10993
- The performed evaluation provides objective evidence to support the o conclusion that the devices can be considered biocompatible for their intended use.
- Shelf-Life testing according to EN ISO 11607
- Sterilization Validation according to EN ISO 11137-1, EN ISO 11137-2. .
- Gamma Sterilization with a confidence sterility assurance level of 10 dB HL: 9/168 patients = 5.4 % (range 11.3-21.3 dB HL)
11
Image /page/11/Picture/0 description: The image shows the logo for MED-EL, a medical device company specializing in hearing implants. The logo is in red and features the company name in bold, sans-serif font. To the right of "MED" is a stylized graphic of a cochlea, also in red, which is a key component of hearing implants.
- Adverse events: ●
- Number of analyzed patients: 188 (127 female, 61 male) o
- Age: mean 47 ± 13 years (range 12-82) റ
- Implanted ear: 98 right, 90 left o
- Follow-up: median 179.0 days (mean 246.4 ± 212.8; range 7-709 days) o
- Prosthesis type: 93 mAXIS, 64 mLOOP, 11 mZAM, 20 mFIX O
- Number of revision surgeries: 0 (2 recommended) o
- o Number of device dislocations/extrusions: 0
- Total 16 AEs in 13 patients: 7 Device unrelated AEs, 2 Medical related O AEs, 2 Clinical/surgical related AEs, 5 AEs "unknown", 0 Follow-up AE
In the above mentioned PMCF investigation the safety and effectiveness of the PMEI Stapesplasty Prostheses was confirmed as demonstrated by postoperative PTA4 ABG