MAUDE Adverse Event Report: SONOVA AG PHONAK ROGER FOCUS II; ATTENTION ASSISTIVE TRAINING DEVICE

Model Number	0563006P8
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Suicidal Ideation (4429)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient experienced suicidal ideation due to continual issues with intermittency of roger focus ii devices.
Additional Manufacturer Narrative
The follow up with the initial reporter established that the patient did not want to wear the devices.The patient is struggling academically and does not like to draw attention to themselves.With several people trying to help the patient to get the devices working both last and this year, this was bringing more attention to the patient, making the patient feel different and not wanting to go to school.The initial reporter refused to answer further questions.It is unconfirmed if the patient tried to act on those thoughts and received any treatment due this conditions.Past history of patient's psychological conditions, suicidal thoughts or other behavioural changes is unknown.It is also unknown if the patient was using the device due to unilateral hearing loss, auditory spectrum disorder (asd) or auditory processing disorder (apd).Analysis of the service history showed that devices were replaced once to a new set of devices due to not functioning.The manufacturer has not recorded any other similar complaints with suicidal ideation or psychological or emotional harm in general for this device.Additionally, no evidence of casual relationship between hearing aids and development of depression or suicidal thoughts exist in the literature.In contrast, using hearing aids has been associated with lower prevalence of depression and some studies demonstrated reduction in depressive symptoms.Devices were serviced/replaced and are not available for the analysis.Additionally, there are no applicable technical tests that could determine the link between device malfunction and suicidal ideation.This is the final report.

• Brand Name: PHONAK ROGER FOCUS II
• Common Device Name: ATTENTION ASSISTIVE TRAINING DEVICE
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 20876983
• Report Number: 3005085999-2024-00025
• Device Sequence Number: 8928450
• Product Code: LZI
• UDI-Device Identifier: 07613389275490
• UDI-Public: (01)07613389275490
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 0563006P8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROGER FOCUS II (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female