Study: NCT02698787

Adverse event: Vertigo/dizziness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: "Whooziness"
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 11 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cerebrospinal fluid release
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Resolved during surgery
Frequency: 1 affected / 11 at risk

Adverse event: Vertigo and dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Electrode tip roll/fold-over
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Low-grade headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ear canal scaly and slightly swollen
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Disabled E12
Serious: no
Organ System: Product Issues
Notes: Poor sound quality and perception
Frequency: 1 affected / 11 at risk

Adverse event: Vertigo and dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 11 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Intermittent non-auditory stimulation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Non-auditory stimulator
Serious: no
Organ System: Product Issues
Notes: Disabled electrode
Frequency: 1 affected / 11 at risk

Adverse event: Change in sound quality
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Impedance spiked
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Change in audibility
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Tenderness around device
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Non-auditory sensation/pain
Serious: no
Organ System: Product Issues
Notes: Disabled electrode
Frequency: 1 affected / 11 at risk

Adverse event: Disabled electrode 14 following pitch ranking
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Intermittent sound
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 11 at risk

Adverse event: Disabled E22
Serious: no
Organ System: Product Issues
Notes: Sound quality and significantly higher threshold and comfort levels
Frequency: 1 affected / 11 at risk

Adverse event: Worsening sinus symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Swelling and slight soreness/sensitivity around internal device
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Profound hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Sudden hearing threshold shift
Frequency: 1 affected / 11 at risk

Adverse event: Vertigo and dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Redness and Indentation at magnet site
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Significant increase in impedances
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Short circuit electrode(s)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Soreness on posterior border of implant
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk