Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus

NCT07298499 | Enrolling By Invitation FDA Device

• 2 other identifiers: StarkeyPMCF2025PMCF2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Post-Market Clinical Investigation whose primary purpose is to evaluate hearing aid amplification and tinnitus masker performance for individuals with hearing loss and tinnitus. There are two primary hypotheses that will be assessed in this study: The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. The use of well-fit amplification in conjunction with a tinnitus masker improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. Participants will be fit with hearing aids for 6 months and a tinnitus masker will be activated at the 3-month mark of the study. Outcome measures will evaluate device performance and participant benefit from the devices throughout the study duration.

Conditions

Hearing Aid; Tinnitus

Keywords

hearing aid benefit

Outcome Measures

Primary Outcomes (6)

• Provision of adequate amplification

  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.

  The 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.

• Device Oriented Subjective Outcome (DOSO) questionnaire to evaluate perceived benefit

  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.

  The time frame of this data collection will occur at session 3 (6 weeks), session 4 (12 weeks), and session 7 (24 weeks)

• Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire

  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.

  The 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)

• Tinnitus Handicap Inventory (THI) questionnaire

  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.

  The time frame of this data collection will occur at session 1 (initial fitting, day 1), session 4 (12 weeks), and session 7 (24 weeks)

• Tinnitus Functional Index (TFI) questionnaire

  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.

  This 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).

• Monitoring of Treatment-Related Adverse Events as Assessed by Otoscopy

  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.

  This 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).

Study Arms (1)

Amplification with or without masker

EXPERIMENTAL

Amplification alone or amplification plus tinnitus masker

Device: Hearing Aid; Device: Tinnitus Masker

Interventions

Hearing Aid DEVICE

Inclusion of hearing aid or not for listening

Amplification with or without masker

Tinnitus Masker DEVICE

Inclusion of tinnitus masker in device

Amplification with or without masker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Native English speaking (defined that all education was done in English)
• Bilateral hearing impairment ranging from mild to profound
• Mild to severe tinnitus
• Ability to commute to research facility

You may not qualify if:

• Participants will be advised to consult promptly a doctor, preferably an ear specialist such as an ENT, prior to being fit with the study devices, if they display any of the following conditions:
• Visible deformity of the ear, either congenital or traumatic
• Fluid, pus, or blood coming out of the ear within the previous 6 months
• Pain or discomfort in the ear
• History of excessive ear wax or suspicion that something is in the ear canal
• Dizziness, either recent or long-standing
• Sudden, quickly worsening, or fluctuating hearing loss within the previous 6 months
• Hearing loss or ringing (tinnitus) only in one ear or a noticeable difference in hearing between ears
• Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz
• Cognitive impairment
• Tinnitus with a somatic origin indicating a need for medical treatment
• Current user of noise masker delivered via a wearable device
• Hyperacusis or extreme sensitivity to sounds
• Is employed by the study sponsor

Sponsors & Collaborators

• Starkey Laboratories, Inc: lead

Study Sites (1)

Starkey Satellite Research Facility Affordable Hearing Centers 6821 W 120th Ave Ste 2H, Broomfield, CO 80020

Broomfield, Colorado, 80020, United States

Location

Related Publications (11)

• Tinnitus Retraining Therapy Trial Research Group; Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 Jul 1;145(7):597-608. doi: 10.1001/jamaoto.2019.0821.

  PMID: 31120533 BACKGROUND

• Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.

  PMID: 8630207 BACKGROUND

• Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.

  PMID: 22156949 BACKGROUND

• Jastreboff PJ, Jastreboff MM. Tinnitus Retraining Therapy (TRT) as a method for treatment of tinnitus and hyperacusis patients. J Am Acad Audiol. 2000 Mar;11(3):162-77.

  PMID: 10755812 BACKGROUND

• Beck JE, Zaugg TL, Egge JL, Lima EN, Thielman EJ. Progressive Tinnitus Management at Two Veterans Affairs Medical Centers: Clinical Implementation With Modified Protocols. Am J Audiol. 2019 Apr 22;28(1S):162-173. doi: 10.1044/2018_AJA-TTR17-18-0040.

  PMID: 31022363 BACKGROUND

• Myers PJ, Griest S, Kaelin C, Legro MW, Schmidt CJ, Zaugg TL, Henry JA. Development of a progressive audiologic tinnitus management program for Veterans with tinnitus. J Rehabil Res Dev. 2014;51(4):609-22. doi: 10.1682/JRRD.2013.08.0189.

  PMID: 25144174 BACKGROUND

• Jastreboff PJ. Tinnitus retraining therapy. Prog Brain Res. 2007;166:415-23. doi: 10.1016/S0079-6123(07)66040-3.

  PMID: 17956806 BACKGROUND

• Del Bo L, Ambrosetti U. Hearing aids for the treatment of tinnitus. Prog Brain Res. 2007;166:341-5. doi: 10.1016/S0079-6123(07)66032-4.

  PMID: 17956798 BACKGROUND

• Cox RM, Alexander GC, Xu J. Development of the Device-Oriented Subjective Outcome (DOSO) scale. J Am Acad Audiol. 2014 Sep;25(8):727-36. doi: 10.3766/jaaa.25.8.3.

  PMID: 25380119 BACKGROUND

• Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.

  PMID: 7789669 BACKGROUND

• Preferred Practice Patterns for the professions of speech-language pathology and audiology. American Speech-Language-Hearing Association. ASHA Suppl. 1993 Mar;35(3 Suppl 11):i-viii, 1-102. No abstract available.

  PMID: 8097652 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Michelle Hicks, Ph.D.

  VP Education and Audiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The participants will have seven lab sessions and six field trials. In the first session, every participant will be fitted with commercially available, post-market prescription hearing aids. Participants will have follow-up sessions after two, six, twelve, eighteen, and twenty-four weeks. The primary safety outcome measure will be gathered at each session. The primary performance outcome measure will be gathered at the initial session. The primary benefit outcome measures pertaining to the benefit of amplification will be gathered at baseline, at twelve weeks, and at twenty-four weeks, and the primary benefit outcome measures pertaining to tinnitus outcomes will be gathered at each session. At the twelve-week session, participants will be fitted with a tinnitus masker using the same commercially available, post-market prescription hearing aids.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: December 23, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)