A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

The primary study goal is to evaluate the histological characteristic of Silk Voice at a surrogate implantation site to evaluate the potential for Silk Voice to deliver long-term results to patients. Information obtained from this study will help clinician determine Silk Voice's treatment duration and whether Silk Voice is appropriate for their patient.

Inclusion criteria

• To be eligible for enrollment, the Subject must meet the following:

• males or non-pregnant, non-breastfeeding females 21 to 65 years old who are willing to comply with the requirements of the study, including sequential photography, periodic check-ins and retrieval of implanted materials;
• women of childbearing potential using an acceptable form of birth control during the study period and willingness to take a urine pregnancy test at baseline and at the biopsy date;
• sign the Informed Consent form and the Authorization for Use and Release HIPAA form prior to any study-related procedures being performed.
• read and understand English

Exclusion criteria

• Patients will not enroll in the study if they meet any of the following exclusion criteria:

• a history of allergy or hypersensitivity to injectable hyaluronic acid gel;
• a history of allergy or hypersensitivity to silk;
• a history of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies
• history of allergies of lidocaine
• a history of susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders.
• currently have a hyaluronic acid device implanted
• the presence of any contraindication to the implant procedures, including use of platelet inhibiting agents or other anticoagulant, in a relevant period before study entry (per the treating investigator's judgment);
• the presence of any condition, which in the opinion of the investigator, that makes the subject unable to complete the study per protocol;
• the presence of known allergies or hypersensitivity reactions to local topical anesthetics or nerve blocking agents (if such products are intended to be used for that subject);
• the presence of cancerous or pre-cancerous lesions in the area to be treated;
• the presence of moderate or severe abnormal rating for firmness or detection of any abnormal structure at the site of injection, such as a scar or lump;
• the current use of immunosuppressive therapy;
• who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at treatment sites
• a history of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis or scleroderma;
• participation in any interventional clinical research study within 30 days prior to randomization;
• subjects not likely to stay in the study for up to 13 months because of other commitments, concomitant conditions, or past history;
• subjects anticipated to be unreliable; or subjects who have a concomitant condition that might confuse or confound study treatments or assessments;
• Subject with skin conditions (discoloration, textured, scarring, etc.) in postauricular region that may complicate study evaluation metrics
• Subjects that are not considered to be an appropriate candidate at the discretion of the investigator.