What this trial measures

• Provision of adequate amplificationThe time frame of this data collection is at the hearing aid fitting which occurs at the initial fitting (Session 1, day 1). This will occur the first time the participant is seen for the study visits.

  Real-ear measures (level of sound at various frequencies measured at the tympanic membrane) will be used to show the hearing aid is providing adequate amplification to compensate for the hearing loss in agreement with a prescriptive fitting formula. The hearing aid responses were measured, and target matched using the Audioscan Verifit system with the ISTS stimuli at various presentation levels (50, 65, and 80 dB SPL). The clinical standard expects measured levels to fall within 5 dB of prescriptive gain targets at 500, 1000, and 2000 Hz, and 8 dB of prescriptive gain targets for 3000 and 4000 Hz.

• Device Oriented Subjective Outcome (DOSO) questionnaire to evaluate perceived benefitThe time frame of this data collection will occur at session 3 (6 weeks), session 4 (12 weeks), and session 7 (24 weeks)

  The Device Oriented Subjective Outcome (DOSO) Scale is used to determine the effectiveness of hearing aids in various situations. This questionnaire is answered by the participant in reflection of their experience with hearing aids. Responses to the questionnaire are based upon the participant's perception of their experience with the hearing aids. The DOSO score is numerical and a higher number corresponds to higher satisfaction between 1 and 7.

• Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaireThe time frame of this data collection will occur at session 1(initial fitting, day 1), session 3 (6 weeks), session 4 (12 weeks), and session 7 (24 weeks)

  The Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire is a widely used measure of hearing aid benefit in a variety of real-life situations. The APHAB is a self-report questionnaire that relies on the participant's perception of their experiences both without hearing aids and after being fit with hearing aids. Scores are numeric between 0 and 100, and difference in score between unaided and aided shows how much of a change is associated with the amplification. Positive numbers mean the amplification provides benefit, while negative numbers mean the amplification is degrading performance.

• Tinnitus Handicap Inventory (THI) questionnaireThe time frame of this data collection will occur at session 1 (initial fitting, day 1), session 4 (12 weeks), and session 7 (24 weeks)

  The Tinnitus Handicap Inventory is a widely used questionnaire to understand the impact of tinnitus on someone's daily life. A numeric score is generated between 0 and 100, and the higher the number, the more handicap is generated by the Tinnitus. A change in score between unaided and aided would show either an increase in handicap or decrease in handicap between unaided and aided conditions.

• Tinnitus Functional Index (TFI) questionnaireThis data will be collected at Session 1(day 1), Session 2 (2 weeks), Session 3 (6 weeks), Session 4 (12 weeks), Session 5 (14 weeks), Session 6 (18 weeks), Session 7 (24 weeks).

  The Tinnitus Functional Index is a widely used questionnaire to understand the multiple domains of tinnitus severity. The outcome is a numeric value between 0 and 100 corresponding to how well the listener can function in various listening situations. The higher number corresponds to increased difficulty functioning, and comparison between unaided and aided conditions determines how much the aided condition improves functioning.

• Monitoring of Treatment-Related Adverse Events as Assessed by OtoscopyThis data will be collected at Session 1(day 1), Session 2 (2 weeks), Session 3 (6 weeks), Session 4 (12 weeks), Session 5 (14 weeks), Session 6 (18 weeks), Session 7 (24 weeks).

  Otoscopy and visual inspection will be conducted at each laboratory visit to examine the structures of the ear that come in contact with the hearing aid, namely the outer ear and the external auditory canal, to look for signs of rubbing, abrasion, or skin reactions which should not occur. Adverse events such as these skin changes or reactions associated with the use of the hearing aids, observed in the study will be reviewed, recorded, and treated according to recommended treatment guidelines to confirm that the devices are not negatively causing soreness or irritation and that the benefits from the devices with respect to hearing and tinnitus outweigh the risks.