Mental illness

– About

– Problem

– Solution

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Something Powerful

Tell The Reader More

The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.

Remember:

  • Bullets are great
  • For spelling out benefits and
  • Turning visitors into leads.

Something Powerful

Tell The Reader More

The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.

Remember:

  • Bullets are great
  • For spelling out benefits and
  • Turning visitors into leads.

Something Powerful

Tell The Reader More

The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.

Remember:

  • Bullets are great
  • For spelling out benefits and
  • Turning visitors into leads.

Something Powerful

Tell The Reader More

The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.

Remember:

  • Bullets are great
  • For spelling out benefits and
  • Turning visitors into leads.

Something Powerful

Tell The Reader More

The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.

Remember:

  • Bullets are great
  • For spelling out benefits and
  • Turning visitors into leads.

Something Powerful

Tell The Reader More

The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.

Remember:

  • Bullets are great
  • For spelling out benefits and
  • Turning visitors into leads.

Something Powerful

Tell The Reader More

The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.

Remember:

  • Bullets are great
  • For spelling out benefits and
  • Turning visitors into leads.

Something Powerful

Tell The Reader More

The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.

Remember:

  • Bullets are great
  • For spelling out benefits and
  • Turning visitors into leads.
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About Device

 

 

 

Regulatory Information – SensoLytics Software

Product Name

SensoLytics
 

Intended Purpose Statement

The SensoDetect® BERA device is a brainstem audiometer (ABR - Auditory Brainstem Response) that records brainstem activity from the auditory neural pathways.

SensoDetect® SensoLytics is a software application intended to perform statistical analysis of auditory brainstem response (ABR) waveform data acquired using the SensoDetect® BERA system. The software extracts, quantifies, and compares electrophysiological signal features from individual patient recordings against a pre-defined reference dataset derived from normative or clinically characterized populations.

The output is presented as a quantitative technical report that includes statistical comparisons and a probability estimate of the analyzed ABR pattern showing a percentage of likelihood of association with specific neurophysiological traits.

The results are intended to be used by healthcare professionals to support the screening and identification of individuals who may benefit from further clinical assessment. The software is not intended to establish a definitive diagnosis, nor is it intended for use in automated clinical decision-making.

Note: The SensoDetect® SensoLytics software is not for sale as a standalone device, and it is intended to work exclusively with the SensoDetect® BERA device.

Note: The SensoDetect® BERA device is not for sale as a standalone device, and it is intended to work exclusively with SensoDetect® SensoLytics software.

Manufacturer Name and Address

SensoDetect AB
Arenagatan 31
215 32 Malmö
Sweden
 

Contact Details

 

Regulatory Status

Version 2025.12.19.1 is a Medical Device under the Conformity Assessment 
 

IFU Availability

E-mail info@sensodetect.com for IFU, with customer number to gain access to the IFU.