Study: NCT02811549

Adverse event: Complication at implant site
Serious: no
Organ System: Surgical and medical procedures
Notes: Implanted ear
Frequency: 1 affected / 15 at risk

Adverse event: Mild Tinnitus, intermittent - Left Ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Non-implanted Ear
Frequency: 1 affected / 15 at risk

Adverse event: Moderate Tinnitus, continuous - Right Ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Implanted Ear
Frequency: 2 affected / 15 at risk

Adverse event: Allergy induced asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Both implanted and non-implanted ear
Frequency: 1 affected / 15 at risk

Adverse event: Granuloma
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Imbalance
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Itching in implanted ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Implanted ear
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Mild ear pressure
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Implanted ear
Frequency: 1 affected / 15 at risk

Adverse event: mild head & neck pain post-surgery
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Numbness, discomfort, or pain at or around the pinna
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Implanted ear
Frequency: 4 affected / 15 at risk

Adverse event: Pain and Anxiety when wearing external device
Serious: no
Organ System: General disorders
Notes: Implanted Ear
Frequency: 1 affected / 15 at risk

Adverse event: Residual hearing loss with a PTA greater than 30dB
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Implanted Ear
Frequency: 9 affected / 15 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Small scab superior pole of incision line related to the patient's haircut
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Jaw Pain when chewing
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Soreness, Tenderness, or Pain at or around the incision site
Serious: no
Organ System: General disorders
Notes: Implanted ear
Frequency: 4 affected / 15 at risk

Adverse event: Tongue Numbness
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Transient Pain
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 1 affected / 15 at risk

Adverse event: Severe Tinnitus - Left Ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Implanted ear
Frequency: 2 affected / 15 at risk

Adverse event: Severe Tinnitus - Right ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Implanted ear
Frequency: 2 affected / 15 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 4 affected / 15 at risk

Adverse event: Vertigo or Dizziness
Serious: no
Organ System: General disorders
Notes: Systemic Adverse Events only
Frequency: 7 affected / 15 at risk

Adverse event: Moderate Tinnitus, continuous - Left Ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Implanted ear
Frequency: 1 affected / 15 at risk

Adverse event: Aural fullness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Implanted ear and Non-implanted Ear
Frequency: 1 affected / 15 at risk