Study: NCT02689349

Adverse event: Fibrotic tissue in middle ear
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as moderate procedure-related SAE in three cases, moderate device-related AE in one case, and as severe SADE in one case.
Frequency: 3 affected / 59 at risk

Adverse event: Facial weakness/paresis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Procedure-related SAE, mild in one case and moderate in two cases.
Frequency: 3 affected / 59 at risk

Adverse event: Incision breakdown
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Adjudicated as procedure-related SAE of moderate severity.
Frequency: 1 affected / 59 at risk

Adverse event: Silicone erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Adjudicated as moderate device-related SAE
Frequency: 1 affected / 59 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Adjudicated as moderate procedure-related SAE
Frequency: 1 affected / 59 at risk

Adverse event: Incision discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adjudicated as mild procedure-related AE
Frequency: 2 affected / 59 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adjudicated as mild procedure-related AE
Frequency: 17 affected / 59 at risk

Adverse event: Uncomfortable sound
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as mild device-related AE.
Frequency: 1 affected / 59 at risk

Adverse event: Eustachian tube dysfunction
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as mild AE
Frequency: 1 affected / 59 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adjudicated as mild procedure-related AE
Frequency: 4 affected / 59 at risk

Adverse event: Air bubble over implant
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adjudicated as mild procedure-related AE
Frequency: 4 affected / 59 at risk

Adverse event: Device cuts out
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as procedure-related AE
Frequency: 1 affected / 59 at risk

Adverse event: Disequilibrium
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as mild, procedure-related AE
Frequency: 2 affected / 59 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as mild AE
Frequency: 6 affected / 59 at risk

Adverse event: Noise or audible artifact
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as mild AE
Frequency: 2 affected / 59 at risk

Adverse event: Clarity or sound quality
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as mild, device-related AE
Frequency: 2 affected / 59 at risk

Adverse event: Suction feeling at implant site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adjudicated as moderate, procedure-related AE
Frequency: 1 affected / 59 at risk

Adverse event: Non-implant hearing aid sound quality
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as mild AE
Frequency: 1 affected / 59 at risk

Adverse event: Lump at implant site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adjudicated as mild device-related AE
Frequency: 1 affected / 59 at risk

Adverse event: Fell and hit head
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adjudicated as moderate AE
Frequency: 1 affected / 59 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as mild, procedure-related AE in two cases, and moderate, procedure-related AE in one case.
Frequency: 3 affected / 59 at risk

Adverse event: Ear drainage
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as mild, procedure-related AE.
Frequency: 2 affected / 59 at risk

Adverse event: Keloids
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adjudicated as mild, procedure-related AE
Frequency: 1 affected / 59 at risk

Adverse event: Incision breakdown
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adjudicated as mild, procedure-related AE
Frequency: 1 affected / 59 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adjudicated as mild procedure-related AE
Frequency: 1 affected / 58 at risk

Adverse event: Device cuts out
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adjudicated as procedure-related AE
Frequency: 1 affected / 58 at risk

Adverse event: High capacitance measurement
Serious: no
Organ System: Product Issues
Notes: Device-related AE
Frequency: 1 affected / 58 at risk

Adverse event: Personal Programmer malfunction
Serious: no
Organ System: Product Issues
Notes: Device-related AE
Frequency: 1 affected / 58 at risk

Adverse event: Limited benefit
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Based on post-market surveillance complaint. Per site, "resolved with medication - no device deficiency noted."
Frequency: 1 affected / 58 at risk